Rachel B Mejia1, Karen M Summers2, Jessica D Kresowik2, Bradley J Van Voorhis2. 1. Department of Obstetrics and Gynecology, University of Iowa Carver College of Medicine, Iowa City, Iowa. Electronic address: rachel-mejia@uiowa.edu. 2. Department of Obstetrics and Gynecology, University of Iowa Carver College of Medicine, Iowa City, Iowa.
Abstract
OBJECTIVE: To evaluate whether a combination of letrozole and clomiphene citrate (CC) results in higher ovulation rates than letrozole alone in infertile women with polycystic ovary syndrome (PCOS). DESIGN: Open-label randomized controlled trial. SETTING: Academic medical center using two clinic sites. PATIENT(S): Women 18-40 years of age with a diagnosis of infertility and PCOS as defined by the Rotterdam criteria and no other known cause of infertility. INTERVENTIONS(S): Participants were randomized in a 1:1 ratio, stratified by age and body mass index, to either 2.5 mg letrozole alone or the combination of 2.5 mg letrozole and 50 mg CC daily on cycle days 3-7 for one treatment cycle. MAIN OUTCOME MEASURE(S): Ovulation defined as mid-luteal serum progesterone concentration ≥3 ng/mL. RESULT(S): Seventy patients were randomized: 35 toletrozole alone and 35 to letrozole and CC. Results were analyzed according to the intention-to-treat principle. Women who received the combination of letrozole and CC had a statistically higher ovulation rate compared with those who received letrozole alone (27 of 35 women [77%] vs. 15 of 35 women [43%]). There were no serious adverse events or multiple-gestation pregnancies in either group. The side-effects profile was similar in the two treatment groups. CONCLUSION(S): The combination of letrozole and CC was associated with a higher ovulation rate compared with letrozole alone in women with infertility and PCOS. Further studies are needed to evaluate the effect on live birth rate. CLINICAL TRIAL REGISTRATION NUMBER: NCT02802865.
RCT Entities:
OBJECTIVE: To evaluate whether a combination of letrozole and clomiphene citrate (CC) results in higher ovulation rates than letrozole alone in infertile women with polycystic ovary syndrome (PCOS). DESIGN: Open-label randomized controlled trial. SETTING: Academic medical center using two clinic sites. PATIENT(S): Women 18-40 years of age with a diagnosis of infertility and PCOS as defined by the Rotterdam criteria and no other known cause of infertility. INTERVENTIONS(S): Participants were randomized in a 1:1 ratio, stratified by age and body mass index, to either 2.5 mg letrozole alone or the combination of 2.5 mg letrozole and 50 mg CC daily on cycle days 3-7 for one treatment cycle. MAIN OUTCOME MEASURE(S): Ovulation defined as mid-luteal serum progesterone concentration ≥3 ng/mL. RESULT(S): Seventy patients were randomized: 35 to letrozole alone and 35 to letrozole and CC. Results were analyzed according to the intention-to-treat principle. Women who received the combination of letrozole and CC had a statistically higher ovulation rate compared with those who received letrozole alone (27 of 35 women [77%] vs. 15 of 35 women [43%]). There were no serious adverse events or multiple-gestation pregnancies in either group. The side-effects profile was similar in the two treatment groups. CONCLUSION(S): The combination of letrozole and CC was associated with a higher ovulation rate compared with letrozole alone in women with infertility and PCOS. Further studies are needed to evaluate the effect on live birth rate. CLINICAL TRIAL REGISTRATION NUMBER: NCT02802865.
Authors: Mohamed Abdel-Maboud; Amr Menshawy; Elfatih A Hasabo; Mohamed Ibrahim Abdelraoof; Mohamed Alshandidy; Muhammad Eid; Esraa Menshawy; Oumaima Outani; Ahmed Menshawy Journal: PLoS One Date: 2021-07-19 Impact factor: 3.240
Authors: Michael Costello; Rhonda Garad; Roger Hart; Hayden Homer; Louise Johnson; Cailin Jordan; Edgar Mocanu; Jie Qiao; Luk Rombauts; Helena J Teede; Eszter Vanky; Christos Venetis; William Ledger Journal: Med Sci (Basel) Date: 2019-09-10