Recombinant FSH increases live birth rates as compared to clomiphene citrate in intrauterine insemination cycles in couples with subfertility: a prospective randomized study

Author(s):  
Mehmet Erdem ◽  
Seraf Abay ◽  
Ahmet Erdem ◽  
Mehmet Firat Mutlu ◽  
Esra Nas ◽  
...  
2020 ◽  
Vol 35 (6) ◽  
pp. 1319-1324
Author(s):  
E M Bordewijk ◽  
N S Weiss ◽  
M J Nahuis ◽  
J Kwee ◽  
A F Lambeek ◽  
...  

Abstract STUDY QUESTION Is endometrial thickness (EMT) a biomarker to select between women who should switch to gonadotropins and those who could continue clomiphene citrate (CC) after six failed ovulatory cycles? SUMMARY ANSWER Using a cut-off of 7 mm for EMT, we can distinguish between women who are better off switching to gonadotropins and those who could continue CC after six earlier failed ovulatory CC cycles. WHAT IS ALREADY KNOWN For women with normogonadotropic anovulation, CC has been a long-standing first-line treatment in conjunction with intercourse or intrauterine insemination (IUI). We recently showed that a switch to gonadotropins increases the chance of live birth by 11% in these women over continued treatment with CC after six failed ovulatory cycles, at a cost of €15 258 per additional live birth. It is unclear whether EMT can be used to identify women who can continue on CC with similar live birth rates without the extra costs of gonadotropins. STUDY DESIGN, SIZE, DURATION Between 8 December 2008 and 16 December 2015, 666 women with CC failure were randomly assigned to receive an additional six cycles with a change to gonadotropins (n = 331) or an additional six cycles continuing with CC (n = 335), both in conjunction with intercourse or IUI. The primary outcome was conception leading to live birth within 8 months after randomisation. EMT was measured mid-cycle before randomisation during their sixth ovulatory CC cycle. The EMT was available in 380 women, of whom 190 were allocated to gonadotropins and 190 were allocated to CC. PARTICIPANTS/MATERIALS, SETTING, METHODS EMT was determined in the sixth CC cycle prior to randomisation. We tested for interaction of EMT with the treatment effect using logistic regression. We performed a spline analysis to evaluate the association of EMT with chance to pregnancy leading to a live birth in the next cycles and to determine the best cut-off point. On the basis of the resulting cut-off point, we calculated the relative risk and 95% CI of live birth for gonadotropins versus CC at EMT values below and above this cut-off point. Finally, we calculated incremental cost-effectiveness ratios (ICER). MAIN RESULTS AND THE ROLE OF CHANCE Mid-cycle EMT in the sixth cycle interacted with treatment effect (P < 0.01). Spline analyses showed a cut-off point of 7 mm. There were 162 women (45%) who had an EMT ≤ 7 mm in the sixth ovulatory cycle and 218 women (55%) who had an EMT > 7 mm. Among the women with EMT ≤ 7 mm, gonadotropins resulted in a live birth in 44 of 79 women (56%), while CC resulted in a live birth in 28 of 83 women (34%) (RR 1.57, 95% CI 1.13–2.19). Per additional live birth with gonadotropins, the ICER was €9709 (95% CI: €5117 to €25 302). Among the women with EMT > 7 mm, gonadotropins resulted in a live birth in 53 of 111 women (48%) while CC resulted in a live birth in 52 of 107 women (49%) (RR 0.98, 95% CI 0.75–1.29). LIMITATIONS, REASONS FOR CAUTION This was a post hoc analysis of a randomised controlled trial (RCT) and therefore mid-cycle EMT measurements before randomisation during their sixth ovulatory CC cycle were not available for all included women. WIDER IMPLICATIONS OF THE FINDINGS In women with six failed ovulatory cycles on CC and an EMT ≤ 7 mm in the sixth cycle, we advise switching to gonadotropins, since it improves live birth rate over continuing treatment with CC at an extra cost of €9709 to achieve one additional live birth. If the EMT > 7 mm, we advise to continue treatment with CC, since live birth rates are similar to those with gonadotropins, without the extra costs. STUDY FUNDING/COMPETING INTEREST(S) The original MOVIN trial received funding from the Dutch Organization for Health Research and Development (ZonMw number: 80-82310-97-12067). C.B.L.A. reports unrestricted grant support from Merck and Ferring. B.W.M. is supported by a NHMRC Practitioner Fellowship (GNT1082548) and reports consultancy for Merck, ObsEva, IGENOMIX and Guerbet. All other authors have nothing to declare. TRIAL REGISTRATION NUMBER Netherlands Trial Register, number NTR1449


Author(s):  
Ankita Singh ◽  
Rohan Palshetkar ◽  
Namrata Singh ◽  
Awyay Rege

Background: Intrauterine insemination (IUI) has been widely used as a common treatment for infertile couples. This study compares the sequential clomiphene citrate (CC) treatment with CC and human menopausal gonadotropin (hMG) treatment in women undergoing IUI. Therefore, this study was designed to determine the effects of addition of gonadotropin (CC+hMG) would improve the pregnancy rate in women undergoing IUI. And also compare the sequential CC+hMG treatment with CC treatment in women undergoing IUI.Methods: A cross-sectional study design was conducted at D. Y. Patil Fertility Centre, D.Y Patil Hospital, Navi Mumbai from September 2018 to August 2019. Source populations were all patients who live in Mumbai, Maharashtra, India. A total of 67 patients were enrolled in this study. (It consisted of 67 sub fertile couples undergoing ovarian stimulation for IUI cycles). Results: There was no significant difference between the two studied groups regarding endometrial thickness (8.3±2.1 versus 9.7±2.8, respectively), number of mature follicles on the day of hCG injection (3.3±1.2 versus 3.5±1.1, respectively) and, but there was significant difference between the CC+hMG group and CC group regarding the total dose of gonadotropins used in ovulation induction (305±23.8 versus 655±192; total IU, respectively) p<0.05.Conclusions: Women undergoing IUI, ovarian stimulation CC combined with hMG, significantly improved the pregnancy and live birth rates as compared to that of CC group. In women undergoing ovarian stimulation and IUI, there are no significant differences in pregnancy and live birth rates among the various stimulation protocols.


Author(s):  
Manish Maladkar ◽  
Chitra Tekchandani ◽  
Akshata Karchodi

Ovulation induction has been a major breakthrough in the management of female infertility since many decades. Letrozole, an aromatase inhibitor has been used as a potential therapy for ovulation induction. A large number of clinical evidences have been emerging which cite the beneficial role of Letrozole in conditions like anovulatory infertility, polycystic ovary syndrome (PCOS), unexplained infertility and an incipient role in endometriosis- related infertility with regards to higher live-birth rates. Letrozole is a superior alternative to Clomiphene citrate (CC) which has been used conventionally as ovulation inducer. Clomiphene citrate has certain well-defined disadvantages, whereas Letrozole overcomes these limitations to a reasonable extent. The peripheral anti-estrogenic effect of CC leads to prolonged depletion of estrogens receptors, adversely affecting endometrial growth and development as well as quantity and quality of cervical mucus. Persistent blockade of estrogen receptor leads to CC resistance and is associated with reduced ovulation and pregnancy rates. Available evidences suggest Letrozole is superior to CC owing to the lack of persistent anti-estrogenic action due to its short half- life and lack of action on estrogen receptors. This typically leads to monofollicular growth and also higher live birth rates. The current evidences suggest that Letrozole can be placed as first line therapy for the management of infertility due to PCOS and unexplained infertility.


2019 ◽  
Vol 201 (Supplement 4) ◽  
Author(s):  
Premal Patel* ◽  
Vinayak Madhusoodanan ◽  
Robert Carrasquillo ◽  
Simon Dadoun ◽  
Ranjith Ramasamy

2014 ◽  
Vol 191 (4S) ◽  
Author(s):  
Natan Bar-Chama ◽  
Michael Elashoff ◽  
Piraye Beim ◽  
Joshua Gonzalez ◽  
Alan Copperman

2018 ◽  
Vol 17 (4) ◽  
pp. 459-465 ◽  
Author(s):  
Takayuki Tatsumi ◽  
Eri Ishida ◽  
Kuniko Tatsumi ◽  
Yumiko Okada ◽  
Takakazu Saito ◽  
...  

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