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

Fertility and sterility, 2019-03, Vol.111 (3), p.571-578.e1 [Peer Reviewed Journal]

2018 American Society for Reproductive Medicine ;Copyright © 2018 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved. ;ISSN: 0015-0282 ;EISSN: 1556-5653 ;DOI: 10.1016/j.fertnstert.2018.11.030 ;PMID: 30683591

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Title:
A randomized controlled trial of combination letrozole and clomiphene citrate or letrozole alone for ovulation induction in women with polycystic ovary syndrome
Author: Mejia, Rachel B. ; Summers, Karen M. ; Kresowik, Jessica D. ; Van Voorhis, Bradley J.
Subjects: Adolescent ; Adult ; Age Factors ; Biomarkers - blood ; Body Mass Index ; Clomiphene - administration & dosage ; Clomiphene - adverse effects ; clomiphene citrate ; combined therapy ; Female ; Fertility - drug effects ; Fertility Agents, Female - administration & dosage ; Fertility Agents, Female - adverse effects ; Humans ; infertility ; Infertility, Female - diagnosis ; Infertility, Female - drug therapy ; Infertility, Female - physiopathology ; Iowa ; Letrozole ; Letrozole - administration & dosage ; Letrozole - adverse effects ; Live Birth ; Ovulation - drug effects ; ovulation induction ; Ovulation Induction - adverse effects ; Ovulation Induction - methods ; polycystic ovary syndrome ; Polycystic Ovary Syndrome - diagnosis ; Polycystic Ovary Syndrome - drug therapy ; Polycystic Ovary Syndrome - physiopathology ; Pregnancy ; Pregnancy Rate ; Progesterone - blood ; Treatment Outcome ; Young Adult
Is Part Of: Fertility and sterility, 2019-03, Vol.111 (3), p.571-578.e1
Description: 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). Open-label randomized controlled trial. Academic medical center using two clinic sites. 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. 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. Ovulation defined as mid-luteal serum progesterone concentration ≥3 ng/mL. 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. 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. NCT02802865. Ensayo controlado aleatorio de letrozol y citrato de clomifeno combinados o letrozol solo para la inducción de la ovulación en mujeres con síndrome de ovario poliquístico Evaluar si una combinación de letrozol y citrato de clomifeno (CC) produce mayores tasas de ovulación que el letrozol solo en mujeres infértiles con síndrome de ovario poliquístico (SOP). Ensayo controlado aleatorio abierto. Centro médico académico utilizando dos clínicas. Mujeres de 18 a 40 años de edad con diagnóstico de infertilidad y SOP, según lo definen los criterios de Rotterdam y sin ninguna otra causa de infertilidad conocida. Las participantes se asignaron al azar en una proporción de 1:1, estratificadas por edad e índice de masa corporal, se les administró 2,5 mg de letrozol solo o la combinación de 2,5 mg de letrozol y 50 mg de CC diariamente en los días 3 a 7 del ciclo para un ciclo de tratamiento. La ovulación se definió como la concentración sérica de progesterona en la mitad de la fase lútea superior o igual a 3 ng / ml. Setenta pacientes fueron aleatorizados: 35 con letrozol solo y 35 con letrozol y CC. Los resultados fueron analizados según el principio de “intención de tratar”. Las mujeres que recibieron la combinación de letrozol y CC tuvieron una tasa de ovulación estadísticamente más alta en comparación con las que recibieron letrozol solo (27 de 35 mujeres [77%] frente a 15 de 35 mujeres [43%]). No hubo efectos adversos graves o embarazos de gestación múltiple en ningún grupo. El perfil de efectos secundarios fue similar en los dos grupos de tratamiento. La combinación de letrozol y CC se asoció con una tasa de ovulación más alta en comparación con letrozol solo en mujeres con infertilidad y PCOS. Se necesitan estudios adicionales para evaluar el efecto sobre la tasa de recién nacidos vivos. NCT02802865.
Publisher: United States: Elsevier Inc
Language: English
Identifier: ISSN: 0015-0282
EISSN: 1556-5653
DOI: 10.1016/j.fertnstert.2018.11.030
PMID: 30683591
Source: MEDLINE
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A randomized controlled trial of combination letrozole and clomiphene citrate or letrozole alone for ovulation induction in women with polycystic ovary syndrome

2018 American Society for Reproductive Medicine ;Copyright © 2018 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved. ;ISSN: 0015-0282 ;EISSN: 1556-5653 ;DOI: 10.1016/j.fertnstert.2018.11.030 ;PMID: 30683591

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