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Randomized Controlled Trial
. 2024 Dec;31(12):3834-3842.
doi: 10.1007/s43032-024-01743-0. Epub 2024 Nov 5.

Comparison of Letrozole Versus Combination Letrozole and Clomiphene Citrate (CC) for Ovulation Induction in Sub Fertile Women with Polycystic Ovarian Syndrome (PCOS)-An Open Label Randomized Control Trial

Sharmistha Sarkar  1 , Nivedita Gupta  1 , Treasa Joseph  1 , Bijesh Yadav  2 , Aleyamma T Kunjummen  3 , Mohan S Kamath  1
Affiliations
Randomized Controlled Trial

Comparison of Letrozole Versus Combination Letrozole and Clomiphene Citrate (CC) for Ovulation Induction in Sub Fertile Women with Polycystic Ovarian Syndrome (PCOS)-An Open Label Randomized Control Trial

Sharmistha Sarkar et al. Reprod Sci. 2024 Dec.

Abstract

To evaluate the effectiveness of Letrozole and Clomiphene (CC) combination versus Letrozole alone for ovulation induction in infertile women with PCOS. This was an open label randomized controlled trial conducted between September 2020 and March 2023 at a tertiary level hospital. Women with a diagnosis of infertility and PCOS were included. Participants were randomized in a 1:1 ratio, to either the combination of 2.5 mg letrozole and 50 mg Clomiphene Citrate (CC) daily or 2.5 mg letrozole alone from 2nd to 6thday of menstrual cycle for up to three treatment cycles. The primary outcome was ovulation rate per cycle. The secondary outcomes included ovulation rate per woman randomised, cumulative pregnancy and live birth rates. A total of the 120 participants, 59 women in Letrozole and CC arm (intervention) and 61 women in the Letrozole alone arm (control) were recruited. The woman per cycle ovulation rate following Letrozole and CC combination versus Letrozole alone (71/92 (77.2%) vs. 52/83 (62.6%), RR 1.43, 95%CI 0.99 to 2.06) but was not statistically significant. A per ITT analysis, the clinical pregnancy rate per woman randomized (16/61(26.2%) vs. 13/59(22%), RR 1.12, 95%CI 0.76 to 1.64) and live birth rate per woman randomized (10/61(16.4%) vs 11/59(18.6%), RR 0.92, 095%CI 0.57 to 1.50) did not differ significantly between Letrozole and CC versus Letrozole group. There was no significant improvement in ovulation, clinical pregnancy, or live birth rates with a combination of letrozole and CC versus letrozole alone in per woman randomized with PCOS. Trial RegistrationThe trial was prospectively registered in the clinical trial registry of India (CTRI registration number CTRI/2020/07/026263), Registration dated: February 26, 2020.

Keywords: Clomiphene citrate; Letrozole; Ovulation induction; Polycystic ovary syndrome; Subfertility.

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Conflict of interest statement

Declarations. Ethics Approval: Ethics committee approval was obtained from the institutional review board (IRB Min. No. 12632 dated 26.02.2020). Consent to Participate: Written consent for the use of anonymized data was obtained from the participants. Consent for Publication: Not applicable. Competing Interests: The authors have no competing interests to declare that are relevant to the content of this article.

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