A randomized controlled trial of combination letrozole and clomiphene citrate or letrozole alone for ovulation induction in women with polycystic ovary syndrome

The combination of letrozole and clomiphene citrate was associated with a higher ovulation rate compared with letrozole alone in women with infertility and poly- cystic ovary syndrome.

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Volume 111, Issue 3, Pages 571–578.e1

Authors:

Rachel B. Mejia, D.O., Karen M. Summers, M.P.H., C.H.E.S., Jessica D. Kresowik, M.D., Bradley J. Van Voorhis, M.D.

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 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.



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Fertility and Sterility

Editorial Office, American Society for Reproductive Medicine

Fertility and Sterility® is an international journal for obstetricians, gynecologists, reproductive endocrinologists, urologists, basic scientists and others who treat and investigate problems of infertility and human reproductive disorders. The journal publishes juried original scientific articles in clinical and laboratory research relevant to reproductive endocrinology, urology, andrology, physiology, immunology, genetics, contraception, and menopause. Fertility and Sterility® encourages and supports meaningful basic and clinical research, and facilitates and promotes excellence in professional education, in the field of reproductive medicine.

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