January 29, 2012

The Founding of the Internet Medical Journal in 1993

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FOUNDING OF THE JOURNAL IN 1993

The Internet Medical Journal was founded in 1993, when Thomas F. Heston, MD was a medical resident at Oregon Health Sciences University. His residency director at the time, Dr. Jerry Glowniak, was a true Internet geek (one of the very first), and visionary in many respects. Domain registration at the time was free through ICNIC.

Dr. Heston designed the first website for the Division of Nuclear Medicine at Oregon Health Sciences University, and started publishing online Tom’s Guide to Good Livin’ in 1993, which eventually became The Internet Medical Journal in 1995.

The first true, 100% online medical journal in the world was created in Great Britain by Dr. Ben Green (Priory Lodge Education Ltd.). This site is a collection of online journals, and Dr. Heston was the first editor of their publication Family Medicine On-Line. Then in 1995, the Internet Medical Journal became the first 100% online medical journal based out of the United States. Heston subsequently founded the Internet Medical Association in 1996.

Heston also was an online instructor for the University of Health Sciences Antigua, which was the first medical school in the world to formally incorporate Internet education into their curriculum. He gave the commencement address to the first graduating class utilizing the innovative online curriculum in Antigua, 2001. It was a windy, blustery, memorable day.

Heston graduated with a distinction in research from the St. Louis University School of Medicine (St. Louis, USA). He did his internship at Duke University, nuclear medicine residency at Oregon Health Sciences University, and family medicine residency at the University of Washington. He is a Fellow of the American Academy of Family Physicians and a Fellow of the American Society of Nuclear Cardiology.

In 1997, he began a private practice in the rural town of Kellogg, Idaho. He practiced the full range of family medicine, including obstetrics and emergency medicine. There was a need in the community for nuclear medicine, and by 2000 Heston had started the first nuclear medicine clinic in Kellogg (in conjunction with Inland Cardiology Associates of Spokane, Washington). This nuclear medicine clinic grew to the point that by 2002, his medical practice was devoted exclusively to nuclear medicine.

Heston is committed to providing healthcare to the under-served, and helped start the first nuclear medicine clinic in Kellogg, Idaho in 2000; the first nuclear medicine clinic in Sandpoint, Idaho (2003); the first nuclear medicine clinic in Post Falls, Idaho (2005); and the first nuclear medicine clinic in St. Maries, Idaho (2006). In addition, he performed the first PET scan in Idaho north of Boise (2003); the first PET/CT fused imaging in north Idaho (2003); the first Fluoride-18 PET bone scan in the the Inland Empire (including Spokane, the Tri-Cities, north Idaho and Montana; 2003); the first PET brain scan in north Idaho (2003); and the first PET heart scan in north Idaho (2003).

Heston was the first physician residency trained in nuclear medicine to practice full-time in north Idaho, and as of early 2006, still the only physician physician board certified in nuclear medicine to have an active medical practice in north Idaho. In late 2006, his medical practice was joined by Dan Sigg, MD, PhD and Mark Wittry, MD, FACC.

He was the first physician in Idaho to become Board Certified in Nuclear Cardiology (1996). In 2006, when the American Society of Nuclear Cardiology began awarding the Fellowship designation, he was in the first group of physicians worldwide to be so recognized.

From the earliest days of the Internet Medical Journal, it was clear that the Internet was a valuable tool to provide online medical news and education to the under-served, especially those communities and those physicians practicing in the poorest, third world countries. Emails have been received from all over the world, thanking Heston for the Internet Medical Journal.

With his unique background in both primary care medicine and also advanced medical and online technology, Heston continues to stay true to his calling of helping the under-served by providing medical news and education over the Internet.

Last updated: 2006

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January 28, 2012

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Medical Mythology: Its Etiology, Prevention and Treatment

By Dr. Thomas F Heston

, Dr. Marc Gosselin

Corresponding Author Dr. Thomas F Heston

Internet Medical Association, 848 N Rainbow Blvd #1289 - United States of America
Submitting Author Dr. Thomas F Heston

Keywords: Mythology, Medicine, Evidence Based Medicine, Folklore, Psychology

How to cite the article: Heston T, Gosselin M. Medical Mythology: Its Etiology, Prevention And Treatment . WebmedCentral GENERAL MEDICINE 2010;1(9):WMC00744

Link to previous version of the article: None

Submitted on: 25 Sep 2010 08:40:19 AM GMT

Published on: 25 Sep 2010 09:27:29 AM GMT

Abstract

Myths are widely held beliefs that are false or of unverifiable existence. In medicine, they are not just unproven theories or mistaken conclusions, rather, they are fictitious ideas that weave their way throughout the profession. In order to prevent and treat medical myths, they need to be recognized as a disease that is harmful to patient care. Using established principles of medicine, the myths then can be medically managed and a cure attempted. To accomplish this, the myths need to be understood in terms of their etiology and pathopsychology. A firm understanding of biostatistics and the principles of evidence based medicine is essential to the prevention, management, and cure of medical myths.

Medical Mythology

Throughout the history of medicine, whenever new ideas are found, we have traditionally gone back to mythology. Much of our medical terminology, anatomy and disease names have origins from mythology, such as Achilles, Atlas, Narcissus and Panic (from the God Pan). This may be secondary to man's discomfort of change, resulting in an immobilization of newer ideas by offering a feeling of security in tradition (1).
In medicine, a myth is a widely held belief that is false or of unverifiable existence (2). it is more than just an unproven theory or mistaken conclusion. Rather, medical myths are fictitious ideas that weave their way through the group psyche of our profession (3). In order to both prevent and treat these myths, we need to recognize them as a disease, and use our medical skills to treat and prevent them. First, we need to thoroughly understand medical mythology and its etiology. With this understanding, we can then design ways to systematically prevent and eradicate the myths. In this article, we will define medical myths, explore their etiology, and finally, propose methods to eradicate old myths and prevent new ones.
Medical myths are irrelevant standards of care that do not help a patient, and occasionally, actually cause harm. They become widely disseminated throughout the profession during medical training through lectures, opinion articles, and textbooks (4). Oral transmission of the myth by other students is perhaps the most powerful vector, however, outside of academic institutions, myths continue to thrive when consultants repeat the fallacies.
An example of a medical myth was the widespread use of hormone replacement therapy (HRT) in women for the primary prevention of coronary artery disease (5). This practice started in the late 1980s and flourished in the 1990s. It quickly became the standard of care. HRT was metaphorically viewed as an elixir of life, and those who did not prescribe HRT were considered uninformed or bad doctors.
The story of HRT for the primary prevention of coronary artery disease highlights a couple of etiologies that are common in the development of a medical myth. First of all, there was solid physiological evidence suggesting a cardioprotective effect of HRT (6, 7). Secondly, there were significant biases in the research, e.g. one major study only looked at caucasians (8), and another only members of a regional health maintenance organization (9). The inappropriate extrapolation of such physiologic evidence and biased research to clinical medicine helped feed and nurture the myth of HRT for primary cardiac prevention.
Ultimately, a large, randomized clinical trial found that HRT was not indicated for the primary prevention of coronary artery disease, or any other chronic disease for that matter (10). Subsequent randomized clinical trials have subsequently refuted the conclusions from the earlier, biased observational studies that HRT was effective as a primary cardioprotective measure. These new clinical trials reached a different conclusion partly due to the fact that they included an evaluation of confounding variables not examined in the previous studies.
For example, while earlier observational studies concluded there was a positive effect of HRT on coronary artery disease, a subsequent randomized clinical trial found that HRT actually increased the risk of stroke and overall cardiovascular disease (11). Furthermore, when the total mortality was evaluated, it was determined that the overall risks of HRT clearly outweighed any possible benefit (12).
Such medical myths are dangerous not only because of their inherent falseness (resulting in suboptimal medical care), but also because they are highly resilient and resistant to change. Myths become especially powerful when they involve issues of life and death, because this emotional component helps turn a myth into a widely distributed meme (13). These memes, which circulate units of cultural information much in the same way genes pass on biological information (14), can become pathological when they propagate false ideas. The memes that transfer false ideas throughout our profession can act like thought viruses (15). If we are to provide the best possible care for our patients, we need to attack these thought viruses head on. We start the process by understanding the etiology of a medical myth.
At its foundation, the etiology of a myth is an incorrect conclusion drawn from good data, or a correct conclusion drawn from bad data. This faulty thinking results in the adoption of a falsehood as truth. One example is when we adopt a hypothesis as true, simply because it makes logical, pathophysiologic sense. Another example is when we blindly accept the teachings of a medical expert without examining the basis of their opinion, or the adoption of a common practice which has not been objectively evaluated (16). A third example is when a poor understanding of biostatistics leads to the misinterpretation of medical research . Putting logic ahead of the scientific method, excessively relying upon expert opinion, and an incomplete understanding of biostatistics all contribute to the etiology of a medical myth. In order to eradicate and prevent myths, we need to address all of these core etiologies.
The eradication of a medical myth needs to focus upon the profession as a whole. Because a false medical theory only grows into a myth when it becomes widely adopted, its cure only comes about when the majority reject the false idea and replace it with a truth. In order to bring this about, the focus is upon the small units, the memes, of a larger myth. As these memes evolve, we come closer to the truth and the myth gradually dies off.
This eradication of mythical memes in medicine is already solidly underway. Perhaps the best example of this is the Cochrane Collaboration, which has instituted a rigorous and systemic approach to the evaluation of the medical literature (17). Furthermore, many medical organizations are doing away with blanket expert opinion consensus statements. Instead, guidelines are presented with a strength of evidence score, which helps acknowledge the deficiencies and gaps in our knowledge (18).
The Internet has also served to treat medical myths by allowing a faster and easier way for nonacademic clinicians to peer review journal articles. A good example of this process are journals which allow the online community to post 'Rapid Responses' to their articles (19). Typically, they publish just about anything that isn't libellous or doesn't breach patient confidentiality, and based on the large number of contributors, the response from the online community has been overwhelmingly positive (20). 'Rapid responders', as they are called, note significant benefits, including the aspects of online peer review (21) and greater attention to the original article (22). One rapid responder even suggested posting research articles anonymously on the journal website before publication, to incorporate an online peer review in addition to the traditional 'expert' peer review (23).
Treating established medical myths, however, will never be fully effective unless strong measures are taken to prevent myths in the first place. Preventing bad data from getting into the medical literature is a primary goal. One way to do this is to minimize the link between the pharmaceutical industry and medical researchers (24). Having authors state any conflicts of interest at the end of the article is not sufficient, because it is now clear that capitalistic interests and monetary profit can affect what research is published, and how it is presented. In addition to conflict of interest disclosures by authors, journal editors and reviewers also need to disclose their conflicts, because of their large impact upon what ultimately gets published (25). Journals also need a quality control system in place to ensure against statistical abuse, which is very easily accomplished (26), especially when conflicts of interest come into play.
The prevention of a myth also requires us to correctly interpret good data. Unfortunately, the medical profession continues to be plagued by innumeracy. For example, internal medicine residents as a group continue to have a worrisome knowledge deficit when it comes to biostatistics (27). This is not a new finding, but rather a long-standing problem that remains unaddressed (28, 29, 30). One study of Danish doctors even concluded that 'the statistical knowledge of most doctors is so limited that they cannot be expected to draw the right conclusions from those statistical analysises which are found in papers in medical journals' (31). While innumeracy pervades society as a whole (32), we must not allow it to be rampant in the medical community. All medical professionals must have at least have a basic understanding of how to interpret biostatistics and understand research methodology. The failure of medical schools and continuing medical education programs in teaching statistics needs to be corrected. One suggestion to help the situation is to require statistical training as a prerequisite to medical school (33).
Although measures are currently underway to treat and prevent medical myths, there continues to be a problem. Medical mythology, the disease, continues to thrive. The implementation of evidence based medicine is a positive step, by reducing our tendency to rely solely on opinions and biased studies rather than observation and the scientific method. Having practice guidelines incorporate 'weight of evidence' scores has also helped, by decreasing the negative effects of expert opinion. However, there remains a suboptimal understanding of biostatistics and research methodology by medical professionals. This problem requires an aggressive approach.
Medical mythology is a robust and resilient virus. We need to be diligent and persistent in our efforts to eradicate this insidious disease.
Thomas F. Heston, MD, PhD
Medical Director, Global Services
Tawam Molecular Imaging Centre
Johns Hopkins International
Baltimore, Maryland, USA

Marc V. Gosselin, MD
Department of Radiology
Oregon Health Sciences University
Portland, Oregon, USA

References

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2. Dickinson G. Medical mythology: an introduction to a new section. CJEM. 2003 Mar;5(2):119. Cited in PubMed; PMID 17475103.

3. Paauw DS. Did we learn evidence-based medicine in medical school? Some common medical mythology. J Am Board Fam Pract. 1999 Mar-Apr;12(2):143-9. Cited in PubMed; PMID 10220238.

4. Flaherty RJ (2004, April 26). Medical mythology. Retrieved May 3, 2008, from http://www.montana.edu/wwwebm/myths/home.htm

5. Abramson BL. Postmenopausal hormone replacement therapy and the prevention of cardiovascular disease: a review. J Cardiovasc Risk 2002 Dec;9(6):309-314. Cited in PubMed; PMID 12478199.

6. Williams JK, Adams MR, Klopfenstein HS. Estrogen modulates responses of atherosclerotic coronary arteries. Circulation 1990 May;81(5):1680-7. Cited in PubMed; PMID 2331772.

7. Barrett-Connor E, Laakso M. Ischemic heart disease risk in postmenopausal women. Effects of estrogen use on glucose and insulin levels. Arteriosclerosis 1990 Jul-Aug;10(4):531-4. Cited in PubMed; PMID 2164381.

8. Bush TL, Barrett-Connor E, Cowan LD, Criqui MH, Wallace RB, Suchindran CM, Tyroler HA, Rifkind BM. Cardiovascular mortality and noncontraceptive use of estrogen in women: results from the Lipid Research Clinics Program Follow-up Study. Circulation 1987 Jun;75(6):1102-9. Cited in PubMed; PMID 3568321.

9. Hernandez-Avila M, Walker AM, Jick H. Use of replacement estrogens and the risk of myocardial infarction. Epidemiology 1990 Mar;1(2):128-33. Cited in PubMed; PMID 2073499.

10. Rossouw JE, Anderson GL, Prentice RL, LaCroix AZ, Kooperberg C, Stefanick ML, et al. Risks and benefits of estrogen plus progestin in healthy postmenopausal women: principal results From the Women's Health Initiative randomized controlled trial. JAMA. 2002 Jul 17;288(3):321-33. Cited in PubMed; PMID 12117397.

11. Anderson GL, Limacher M, Assaf AR, Bassford T, Beresford SA, Black H, et al. Effects of conjugated equine estrogen in postmenopausal women with hysterectomy: the Women's Health Initiative randomized controlled trial. JAMA 2004 Apr 14;291(14):1701-12. Cited in PubMed; PMID 15082697.

12. Heiss G, Wallace R, Anderson GL, Aragaki A, Beresford SA, Brzyski R, et al.Health risks and benefits 3 years after stopping randomized treatment with estrogen and progestin. JAMA 2008 Mar 5;299(9):1036-45.Cited in PubMed; PMID 18319414.

13. Bell C, Sternberg E. Emotional selection in memes: the case of urban legends. J Pers Soc Psychol 2001 Dec;81(6):1028-41. Cited in PubMed; PMID 11761305.

14. Dawkins R. The selfish gene. New York: Oxford University Press, USA. 1990.

15. Lofland D. Thought viruses: powerful ways to change your thought patterns and get what you want in life. New York: Three Rivers Press; 1997. p 32.

16. Glantz SA. Primer of biostatistics. New York: McGraw-Hill; 2002. p 3.

17. Godlee F. The Cochrane collaboration. BMJ. 1994 Oct 15;309(6960):969-70. Cited in PubMed; PMID 7950714.

18. American College of Cardiology. Methodologies and policies from the ACC/AHA task force on practice guidelines. acc.org 2006. http://acc.org/qualityandscience/clinical/manual/pdfs/methodology.pdf (accessed 19 May 2008). p 30-37.

19. Crossan L, Delamothe T. Letters to the editor: the new order. Please respond to articles using website, email, or disk-but not paper. BMJ 1998 May 9;316(7142):1406-10. Cited in PubMed; PMID 9572748.

20. Delamothe T, Smith R. Twenty thousand conversations. BMJ 2002 May 18;324(7347):1171-2. Cited in PubMed; PMID 12016170.

21. Jacobs A. Rapid responses are the best form of peer review. bmj.com 2004. http://bmj.bmjjournals.com/cgi/eletters/328/7436/413#50612 (accessed 16 May 2008).

22. Vasenwala M. Joy of rapid responses. Readers read articles more closely when they can respond. BMJ 2004;328(7440):645. Cited in PubMed; PMID 17726834.

23. Ilangaratne J. Mina Fazel's cri de coeur. bmj.com 2004. http://bmj.bmjjournals.com/cgi/eletters/328/7436/413#50467 (accessed 16 May 2008).

24. Moynihan R, Cassels A. Selling sickness: how the world's biggest pharmaceutical companies are turning us all into patients. New York: National Books; 2005.

25. Cooper RJ, Gupta M, Wilkes MS, Hoffman JR. Conflict of Interest Disclosure Policies and Practices in Peer-reviewed Biomedical Journals. J Gen Intern Med 2006 Dec;21(12):1248-52.Cited in PubMed; PMID 17105524.

26. Huff D. How to lie with statistics. New York: W.W. Norton & Company; 1993.

27. Windish DM, Huot SJ, Green ML. Medicine residents' understanding of the biostatistics and results in the medical literature. JAMA 2007 Sep 5;298(9):1010-22. Cited in PubMed; PMID 17785646.

28. West CP, Ficalora RD. Clinician attitudes toward biostatistics. Mayo Clin Proc. 2007 Aug;82(8):939-43.Cited in PubMed; PMID 17673062.

29. Laopaiboon M, Lumbiganon P, Walter SD. Doctors' statistical literacy: a survey at Srinagarind Hospital, Khon Kaen University. J Med Assoc Thai 1997 Feb;80(2):130-7. Cited in PubMed; PMID 9078698.

30. Matthews DR, McPherson K. Doctors' ignorance of statistics. Br Med J (Clin Res Ed). 1987 Apr 4;294(6576):856-7. Cited in PubMed; PMID 3105774.

31. Wulff HR, Andersen B, Brandenhoff P, Guttler F. What do doctors know about statistics? Stat Med. 1987 Jan-Feb;6(1):3-10. Cited in PubMed; PMID 3576014.

32. Dewdney AK. 200% of nothing. New York: John Wiley & Sons; 1993. p. 1-2.

33. Horton NJ. Clinician attitudes toward biostatistics [letter]. Mayo Clin Proc 2007;82(12):1578-1579. Cited in PubMed; PMID 18053469.

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January 24, 2012

Intrauterine insemination versus Fallopian tube sperm perfusion in non-tubal infertility

AUTHORS: Dr. Col (Retd) G S Shekhawat, MD(Obst & Gyn) * (Corresponding. Author), Dr Priyanka S, MBBS+

PLACE OF RESEARCH WORK: Assisted Reproductive Technology center, Armed Forces Medical College/ Command Hospital (Southern Command), Pune-411040 and 92 Base Hospital PIN -901218 C/O 56 APO

ADDRESS OF THE AUTHORS:

* Associate professor, Dept of Obstetrics & Gynecology, Smt Kashibai Navale Medical College, Narhe, Pune-411041, Maharashtra.

Email: gsshekhawata@yahoo.co.in, Tel :( M) 9372897090,

+Medical Officer, Smt Kashibai Navale Medical College, Narhe, Pune-411041, Maharashtra.

INTELLECTUAL CONTRIBUTIONS:

Study concept: Dr G S Shekhawat

Drafting and Manuscript revision: Dr Priyanka S

Statistical analysis: Dr Priyanka S

Study supervision: Dr G S Shekhawat

ABSTRACT:

Background: Controlled ovarian hyper stimulation (COH) combined with intrauterine insemination (IUI), using a volume of 0.5 mail of inseminate is commonly offered to couples with non tubal infertility. Another method is Fallopian tube sperm perfusion (FSP) which is based on a pressure injection of 4 ml of sperm suspension while attempting to seal the cervix to prevent semen reflux. This technique ensures the presence of higher sperm density in the fallopian tubes at the time of ovulation than standard IUI. The aim of this study was to compare the efficiency of IUI and FSP in the treatment of infertility.

Methods: 200 consecutive patients with infertility in 404 stimulated cycles were included in the study. Those randomized to standard IUI included 100 patients in 184 cycles [158 Clomiphene citrate/human menopausal gonadotrophin cycles and 26 Letrozole/FSH cycles exclusively for polycystic ovarian disease patients] (group A). Patients subjected to FSP included 100 patients in 220 cycles (193 Clomiphene citrate/human menopausal gonadotrophin cycles and 27 Letrozole/FSH cycles exclusively for polycystic ovarian disease patients] (group B). Swim up semen preparation technique was used in all cases. Insemination was performed in both groups 34-37 hours after hCG administration. Standard IUI was performed using 0.5 ml of inseminate. In FSP 4ml inseminate was used.

Results: In group A (184 IUI cycles in 100 patients), 22 clinical pregnancies (presence of gestational sac with fetal cardiac activity) occurred (11.95% per cycle over four cycles). In group B, (220 cycles of FSP in 100 patients), 48 clinical pregnancies occurred (21.81%per cycle over four cycles) and this difference was statistically significant (p<0.05).

Conclusions: For non-tubal sub fertility, the results indicate clear benefit for FSP (Fallopian tube sperm perfusion) over IUI (Intrauterine insemination).

Key Words: Intrauterine insemination, Fallopian tube sperm perfusion, Non-tubal infertility.

Introduction

Intrauterine insemination (IUI) with mild ovarian stimulation has been used for many years in the treatment of non tubal infertility. During IUI, pretreated semen is concentrated in a small volume of 0.5 ml and deposited by a catheter into the uterine cavity. The overall pregnancy rates reported in the literature ranged from 5.7% to 17.7% per cycle [1]. Although the number of available oocytes can be increased by ovarian stimulation, the pregnancy rates in IUI are still not promising, mainly because of suboptimal spermatozoa at the site of fertilization [2]. An alternative procedure, termed Fallopian tube sperm perfusion (FSP), has been reported with improved pregnancy rates in comparison with IUI [3, 4, and 5]. In FSP, sperm preparation is identical to that used in IUI, but the spermatozoa are diluted in a larger volume of medium up to 4 ml [6]. This volume has been considered sufficient for bilateral passage of the spermatozoa through the fallopian tubes. Theoretically, this would increase the density of capacitated spermatozoa near the oocytes and result in higher pregnancy rates. A prospective randomized study was designed to determine whether FSP resulted in higher pregnancy rates than IUI.

Material & Methods

Two hundred infertile patients, aged 17 to 39 years, undergoing 404 consecutive cycles of ovarian stimulation were studied from June 2007 to Jan 2009. Institutional board approval was obtained. These patients underwent a basic infertility workup including confirmation of tubal status by hysterosalpingogram or laparoscopy and hormone profile including serum follicle stimulating hormone (FSH), luteinizing hormone (LH), prolactin and thyroid hormone tests. Menstrual cycle day 3 basal transvaginal ultrasonography was done in all cases to rule out ovarian cysts prior to ovulation stimulation. Exclusion criteria were age > 39 years, obstructed fallopian tubes and cases with marked oligospermia sperm count<10X106per ml).

The patients were classified for purpose of etiology of infertility as having mild and moderate endometriosis; ovulatory disorders (hormonal profile and transvaginal sonography characteristic of polycystic ovarian syndrome); cervical hostility (poor properly timed post-coital test); male sub fertility (as per WHO criteria) [7]; unexplained infertility (where no infertility causes were found).

These patients underwent ovulation induction with either Clomiphene citrate and Human menopausal gonadotrophin (351 cycles in 174 patients) or Letrozole and FSH used exclusively for polycystic ovarian disease patients (53 cycles in 26 patients). The ovarian stimulation protocol of clomiphene and hMG (Human menopausal gonadotrophin) was used in 170 patients. It consisted of clomiphene citrate 100 mg daily on days 3-7 of the cycle, and 75 IU daily of hMG (Human menopausal gonadotrophin) on days 6-9 of the cycle. For some of the women, hMG was increased to 150 IU in subsequent cycles, depending on the previous ovarian response. Rotterdam ESHRE consensus workshop criteria (2003) was used for diagnosis of PCOS. In all PCOS patients (26 patients), who had been on Metformin 500 mg t.i.d , Letrozole was given orally in a dose of 2.5mg/day for 5 days starting from day 3 of a spontaneous or progesterone induced menstrual bleeding . Inj purified FSH 75 IU administered on 6-9 day of menstrual cycle.

Cycles were monitored from day 9 onwards by transvaginal ultrasound measurement of the number and diameter of the growing follicles along with the thickness and morphology of the endometrium. A dose of 10,000 IU human chorionic gonadotrophin (hCG) was administered when at least one leading follicle had reached a diameter of 18 mm and at least 8 mm endometrial thickness with tri laminar ‘halo’ appearance seen. Patients were called 34 to 36 hours later, and either standard IUI (group A: 184 cycles in 100 patients) or FSP (group B: 220 cycles in the 100 patients) was performed. The patients were counseled about the two alternative procedures and informed consents were obtained before randomization. Patients were allocated randomly to standard IUI or FSP on the day of insemination in the first cycle itself, according to even or odd serial number in the register. Maximum of four cycle treatments of IUI or FSP were considered for those patients who could not conceive in previous attempts. However those who failed to conceive with IUI were offered IUI only and vice versa.

132 male partners were normozoospermic with count > 20X106 sperm per ml, >50% motile with forward progression (categories a and b) within 60 min of ejaculation and > 60% morphologically normal spermatozoa (WHO criteria) [7]. Male partners with sperm count ranging from 10X106 to 20X106 were asked to produce a second semen sample within 2 hours of the first sample on the day of insemination. Sixty-eight males having sub fertility as per WHO criteria did consent to the study. However 04 could not produce a second sample at the time of IUI, and 1 patient had total sperm immotility and was excluded from the study. A fresh ejaculate was delivered in a sterile 60 ml jar by masturbation on the day of insemination. Neat semen was left at room temperature for liquefaction for 30 minutes.The liquefied semen samples were analyzed for density and motility using a fixed-depth counting chamber (Makler). The liquefied ejaculate was transferred to a labeled sterile 14 ml round-bottomed disposable centrifuge tube (Falcon No.2095) and 4 ml flushing media (Medicult) added to it. After thorough mixing the sample was centrifuged at 5000 rpm for 10 minutes. Then, the supernatants were discarded and the pellet was resuspended and mixed in 3 ml of fresh flushing media (Medicult) and centrifuged for second wash again at 5000 rpm for 10 minutes. Once again the supernatants were discarded. Each pellet was now gently layered with 0.5 ml for IUI and 4 ml for FSP of universal IVF media (Medicult), and incubated at 37oC in a humidified incubator with 5% Carbon dioxide for 1 hour. Post wash semen analysis was done in all cases using Makler’s counting chamber before insemination.

Intrauterine insemination was performed with conventional catheter using 0.5 ml of inseminate. To eliminate dead space problem, IUI catheter was first attached to syringe and then inseminate was aspirated. In FSP 4ml inseminate was used and backflow of inseminate was occluded at the cervical opening by the long size Allis clamp (Figure-1), which was suitably modified by attaching cervical occluding prongs with rubber cushions to avoid trauma to the cervix and was kept in place for about 3 to 4 minutes after insemination. In both groups, the patient rested for 30 minutes after insemination and received oral micronized progesterone 100 mg, two tablets per day for luteal-phase support.

Values were recorded as mean ± SD using Microsoft Excel version 4. Statistical analysis were performed using student’s t-test for testing significance of difference between the means and the X2test to compute p-values for testing the agreement between proportions. MedCalc statistical software (Meriakerke, Belgium) version 9.5.0.0 was used for all statistical analysis. The significance was defined as p < 0.05.

Results

The patient characteristics for group A and B were not significantly different concerning patient’s age (28.42 ± 2.78 years and 28.19 ± 2.80 years), type of sterility (primary infertility 74% versus 72% respectively) and duration of infertility (5.6 ± 2.1 and 5.3 ± 1.9 years respectively). The clinical indications for IUI or FSP were also not significantly different for the two groups (endometriosis 12% versus 12%, polycystic ovarian syndrome 34% versus 36%, cervical 4% versus 4%, unexplained 18% versus 12% and male factor sub fertility 32% versus 36% respectively). The ovarian stimulation protocol for group A and B were not significantly different (clomiphene citrate/hMG 85% versus 87% and Letrozole/FSH 15% versus 13% respectively). The parameters of cycle monitoring for group A and B including number of follicles=18 mm diameter(3.93±1.37 versus 3.90±1.17), endometrial thickness on the day of hCG administration (9.19±0.58mm versus 9.14±2.1mm) and the number of spermatozoa(38.83±16.57X106 versus 36.68±13.44X106) inseminated were not significantly different. However the day of hCG administration (12.8±3.4 versus 11.1±2.1) was significantly different between the two groups as shown in table-1 and 2.

Clinical pregnancy was defined by the presence of fetal cardiac activity, detected by ultrasound examination. Pregnancy rates were similar when compared for the etiology of infertility: for ovarian (PCOS) cause (17.7% versus 21.8%), endometriosis cause (8.4% versus 10.1%), male infertility (12.8% versus 16.4%) and unexplained infertility (14.4% versus 24%) for the two groups, respectively as shown in table-3. There was statistically significant difference (p<0.05) in the overall pregnancy rate per cycle over four treated cycles (11.95% per cycle for IUI versus 21.81% per cycle for FSP over four cycles) as shown in table-4. Two missed abortions and one twin pregnancy occurred among the patients in group A (IUI). Three missed abortions and two twin pregnancies occurred among the patients in group B (FSP). However, this limited number of abortions and multiple pregnancies are too low to allow testing for statistical significance. Three cases of mild ovarian hyper stimulation syndrome (OHSS) occurred in both groups.

Discussion

The purpose of this prospective, randomized study was to study pregnancy rates in couples with nontubal infertility when treated with FSP (inseminate volume 4 ml), in comparison with standard IUI (inseminate volume 0.5 ml). Pregnancy rates were 21.81 and 11.95% respectively over four treatment cycles. The same protocols for ovarian stimulation were used in both groups. There was no statistically significant difference regarding the age of the patients treated, mean number of follicles, endometrial thickness on the day of hCG administration and the total number of motile spermatozoa inseminated. However the day of hCG(12.8±3.4 for FSP versus 11.1±2.1 for IUI) administration was statistically different between the two groups (p value <0.05).

Kahn et al. reported the first clinical experience with FSP. In their study, they used a Frydman catheter for FSP and reported a pregnancy rate per cycle of 26.9% in patients with unexplained infertility and of 2.7% to 7.7% in patients with other etiologies. These excellent results, particularly in patients with unexplained infertility, were confirmed by other studies [8]. Some investigators used a paediatric Foley catheter or cervical clamp double-nut bivalve speculum and very encouraging results were reported by Fanchin et al, in which FSP using an auto blocking device (FAST system) doubled their pregnancy rates from 20% to 40% [1].The different types of catheters used for IUI have been compared but no study reports a significantly higher rate of pregnancy with any one type of catheter [9, 10].

The FSP increases the intrauterine pressure(70-200 mmHg) necessary for a flush influx of spermatozoa directly into the fallopian tubes. The high pregnancy rate per cycle for FSP as compared with standard IUI can be due to several causes as follows: firstly, the pressure injection of inseminate can either remove and/or circumvent transitory or partial obstruction of fallopian tubes, such as that created by thick mucus or tubal polyps; secondly, the concentration of motile spermatozoa around the oocytes after FSP is higher than that obtained after standard IUI; and thirdly, FSP leads to inseminate overflowing into the pouch of Douglas. The more accepted hypothesis is the existence of a similar mechanical effect created following a hysterosalpingography [10].

In this study, we tried to evaluate FSP not only in patients with unexplained infertility but also in patients with other causes of infertility including male causes. Two different stimulation regimes were used; however, the distribution of the two types of stimulation protocols (clomiphene citrate/hMG and Letrozole/FSH) appeared homogenous in both studies groups.

Clinical pregnancy was defined by the presence of fetal cardiac activity, detected by ultrasound. When comparing the pregnancy rates in both IUI and FSP in relation to the etiology of infertility, it is found to be statistically similar as shown in table-3. Though the pregnancy rates of FSP in PCOS and unexplained infertility group of patients is superior to IUI, this finding is statistically not significant. This analysis revealed that couples suffering from any specific etiological sub fertility did not benefit from FSP over IUI.

However, there was statistically significant difference in the overall pregnancy rate per cycle over four cycles of treatment (11.95% per cycle over four cycles for IUI versus 21.81% per cycle for FSP over four cycles) as shown in table-4(p value<0.009). Pregnancy rates improved in subsequent attempts with FSP in comparison to IUI. The cumulative pregnancy rates even after the second attempt, over two cycle treatment, were statistically significant (p value <0.03), however there was no statistical difference when each attempt of treatment cycles was compared between the two groups (p value >0.05).

Four studies [2, 4, 6, and 11] mentioned a maximum of three cycles per couple; one study [12] reported a maximum of four cycles. We also allowed maximum of four cycles treatment of IUI or FSP before considering them for In vitro fertilization and embryo transfer (IVF-ET).

The type of catheter has no impact on the pregnancy rate after intrauterine insemination [13]. We suitably modified the long size allis clamp, by attaching cervical occluding prongs with rubber cushions, which was kept in place for about 3 to 4 minutes after insemination to prevent any significant reflux. Mild reflux does not seem to influence the results of the FSP but the significant reflux (> 0.4 ml) may reduce the pregnancy [14]. If more than 1 ml comes back in the catheter, the operator needs to wait for a few minutes and re-inseminate again. All the authors agreed that women tolerated the FSP technique very well. In our study some patients complained of post insemination pelvic transient pain, more so in FSP than in IUI. Other interesting domain of FSP application is the immunological infertility in the presence of anti-sperm antibodies [15, 16].This aspect could not be studied in this study because pre and post FSP anti-sperm antibody assay was not done.

In this study by comparing the overall results, we conclude that FSP over four cycles of treatment offers an advantage over the standard IUI, and can replace the IUI for all its indications because of its better pregnancy rates. However FSP is more expensive than IUI due to the increased media usages. It could be used as an alternative for couples with non tubal infertility before embarking on IVF-ET treatment.

References

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FIGURE 1

Intrauterine insemination versus Fallopian tube sperm perfusion in non-tubal infertility

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