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Rapid Responses: Rapid Responses published:
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11 or 17 more babies
- Cher Redmond (9 August 2008)
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Are common treatments for infertility really all the same?
- andrew owen (15 August 2008)
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Low dose of clomiphene citrate vs. expectant management
- G. David Adamson (29 August 2008)
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It ain't necessarily so...the BMJ editorial conclusion needs a second thought
- Zeev Blumenfeld, Haifa 31096 (4 September 2008)
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Subclinical Endometriosis
- Gangadhara Rao Koneru (15 September 2008)
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IDIOPATHIC INFERTILITY-ICSI
- KONERU GANGADHARA RAO, BHATTACHARYA.S,K.HARRYLD (16 November 2008)
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Cher Redmond, researcher Davis, US, 95616
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The authors work with infertile mothers but to them the difference in the number of babies - 17 more from IUI than clomid and 11 more from IUI than nothing is not statistically significant. I doubt the mothers or other infertile women think that those numbers are insignificant. Imagine that a doctor tells a woman with a family history of cancer that clomid is better than IUI. Is that insignificant? Competing interests: None declared |
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andrew owen, consultant Cardiologist Kent and Canterbury Hospital, Canterbury, Kent, UK. CT1 3NQ
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The authors conclude that common treatments for infertility do not seem to enhance fertility. This rather vague statement has been taken up by the media as meaning that these treatments do not work. The authors’ data do not disprove their null hypothesis of no difference between treatments. This however does not mean the null hypothesis is true i.e. the treatments are all equally efficacious. The null hypothesis can never be proven. If the authors were expecting little difference between treatments they should have pre specified a non inferiority analysis. Competing interests: None declared |
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G. David Adamson, President, American Society for Reproductive Medicine; Director, Fertility Physicians of Northern CA Palo Alto, CA 94301 USA
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The authors of “Clomifene citrate or unstimulated intrauterine insemination compared with expectant management for unexplained infertility: pragmatic randomize controlled trial” are to be congratulated on an excellent trial and its presentation. (1) We agree with them that, “Our choice of clinical protocols for the intervention arms reflects current practice in Scotland and the rest of the UK, but the results might not be generalisable to other populations and alternative drug regimens.” For example, in the United States infertility patients generally are older with longer duration of infertility and receive higher doses of stimulatory drugs. Importantly, the authors state that, “In particular, this trial does not address the issue of a combined approach with clomifene citrate and intrauterine insemination, which should be the focus of future trials.” Indeed, the low dose of clomiphene citrate used and the criteria of cancelling cycles would not be expected to result in higher pregnancy rates than expectant management in many patients. Additional, larger randomized trials with appropriate controls are needed to confirm the potential and biologically plausible benefits of clomiphene citrate plus IUI at this and higher doses in this and other populations. It is also reasonable but not yet demonstrated to think that pregnancy rates with IUI would be higher if couples followed the usual regimen of timed intercourse plus one LH-surge-timed IUI. The optimal choice for fertility treatment depends on a careful clinical assessment and the individualized needs of each patient. Such assessment is often complex, and can best be performed by physicians with special expertise in infertility, especially because financial, time, health and emotional costs can be significant if less than optimal care is provided. REFERENCES 1. Bhattacharya S,Harrild K, Mollison J, Wordsworth S, Tay C, Harrold A, McQueen D, Lyall H, Johnston L, Burrage J, Grossett S, Walton H, Lynch J, Hohnstone A, Kini S, Raja A, Templeton A. Clomifene citrate or unstimulated intrauterine insemination compared with expectant management for unexplained infertility: pragmatic randomized controlled trial. BMJ 2008;337:a716. doi:10.1136/bmj.a716. Competing interests: Fertility Physicians of Northern California received research funding from Serono and IBSA. |
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Zeev Blumenfeld, Associate Professor Ob Gyn RAMBAM Med Ctr & Technion, Israel Institute of Technology, Haifa 31096
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I have read with great interest the recent manuscript by Bhattacharya et al[1] and the following BMJ editorial[2] regarding this publication. The conclusion of Bhattacharya et al[1]: "In couples with unexplained infertility existing treatments such as empirical clomifene and unstimulated intrauterine insemination are unlikely to offer superior live birth rates compared with expectant management" is not entirely accurate since it suggests other "existing treatments" are also not better than expectant management, which is not the case. Moreover, the BMJ editorial[2] regarding this publication, concludes that:"However, on the basis of the best evidence available, in vitro fertilisation seems to be the most cost effective intervention.[1,2]", according to Pashayan et al[3] calculations, based on the assumption that the live birth rate following gonadotrophin-stimulated IUI is 7% per cycle[3]. However, more recent publications have found the pregnancy rate after recombinant FSH COH and IUI to be 25.9% [4], [compatible with a live birth rate of more than double of that cited by Pashayan et al][3]. A 10–20% clinical pregnancy rates per cycle of IUI after COH is regarded as acceptable range for most infertility aetiologies by others[4- 6], even in earlier publications, in the 80th and 90th [4-6]. Most recently, Erdem et al [7] have found live birth rate per patient and per cycle to be 21.1% and 11.4%, respectively. By multivariate logistic regression analysis they[7] have demonstrated that significant independent factors to predict successful pregnancy and live birth are: duration, aetiology, and infertility type, number of treatment cycles and number of dominant follicles. They concluded, therefore, that infertile couples are likely to successfully achieve a live birth with IUI treatment after COH using recombinant gonadotrophins. IVF is considered a safe procedure for both mother and offspring, but it is not completely without risks; - hyperstimulation, complications from anesthesia, bleeding, thrombosis, and infection are all well-known risks. Moreover, an older metaanalysis, [8] analyzing cost-benefit comparing hMG-COH with IUI, IVF, and no therapy in infertility patients has concluded to favor four cycles of hMG-COH with IUI as the first line of therapy. Using meta-analysis and theoretical assumptions, the pregnancy rate for one cycle of hMG and IUI was inferior to IVF; two cycles were comparable to IVF whereas three-four cycles were found to be more successful than an IVF cycle[8]. Therefore, although there is no doubt IVF is a wonderful technology which has brought a blessed revolution to millions of infertile patients, I believe the logic and cost effective algorithm should be to experience 3 -4 cycles of COH-IUI to infertile couples younger than 35 years, and fall back to IVF only if unsuccessful. I believe the BMJ editorial conclusion needs a second thought… Zeev Blumenfeld, MD
References 1. Bhattacharya S, Harrild K, Mollison J, Wordsworth S, Tay C, Harrold A, McQueen D, Lyall H, Johnston L, Burrage J, Grossett S, Walton H, Lynch J, Johnstone A, Kini S, Raja A, Templeton A. Clomifene citrate or unstimulated intrauterine insemination compared with expectant management for unexplained infertility: pragmatic randomised controlled trial. BMJ. 2008 Aug 7;337:a716. doi: 10.1136/bmj.a716. 2. El-Toukhy TA, Khalaf Y. Treatment of unexplained infertility. BMJ – Editorial. 2008;337:772. 3. Pashayan N, Lyratzopoulos G, Mathur R. Cost- effectiveness of primary offer of IVF vs. primary offer of IUI followed by IVF (for IUI failures) in couples with unexplained or mild male factor subfertility. BMC Health Serv Res. 2006 Jun 23;6:80. 4. Demirol A, Gurgan T. Comparison of different gonadotrophin preparations in intrauterine insemination cycles for the treatment of unexplained infertility: a prospective, randomized study. Hum Reprod. 2007 Jan;22(1):97-100. 5. Allen NC, Herbert CM, III, Maxson WS, Rogers BJ, Diamond MP and Wentz AC (1985) Intrauterine insemination: a critical review. Fertil Steril 44,569–580. 6. Ombelet W, Puttemans P and Bosmans E (1995) Intrauterine insemination: a first-step procedure in the algorithm of male subfertility treatment. Hum Reprod 10(Suppl 1),90–102. 7. Erdem A, Erdem M, Atmaca S, Korucuoglu U, Karabacak O. Factors affecting live birth rate in intrauterine insemination cycles with recombinant gonadotrophin stimulation. Reprod Biomed Online. 2008 Aug;17(2):199-206. 8. Peterson CM, Hatasaka HH, Jones KP, Poulson AM Jr, Carrell DT, Urry RL. Ovulation induction with gonadotropins and intrauterine insemination compared with in vitro fertilization and no therapy: a prospective, nonrandomized, cohort study and meta-analysis. Fertil Steril. 1994 Sep;62(3):535-44. Competing interests: None declared |
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Gangadhara Rao Koneru, Professor in OBG NRI Medical College,Vijayawada,AP,India
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As observed by some authors, there will be subclinical endometriosis contributing to the infertility of unknown cause. The incidence of subclinical endometriosis is around 42%.Treating such patients by giving midcycle progesterones the conception rates were observed to be higher. After 6 months of treatment with midcycle progesterones combined with Intrauterine insemination and without any ovulation induction in idiopathic infertility patients the pregnancy otcome will be more. In our observation we can even increase midcycle progesterone dose by 10- 30mg/day in increments of 10mg/day seem to be beneficial. Competing interests: None declared |
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KONERU GANGADHARA RAO, Professor in OBG NRI Medical College,Vijayawada,AP,India, BHATTACHARYA.S,K.HARRYLD
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AFTER 3-4YRSOF ROUTINE TREATMENT OF infertity if no results one can try cc,hmg,hcgfor 3-5cycles.if this also fails we can try ovulation inductionand icsi for3-4cycles. Competing interests: IDIOPATHIC INFERTILITY |
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