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A randomized controlled trial of clomifene citrate, metformin, and pioglitazone versus letrozole, metformin, and pioglitazone for clomifene‐citrate‐resistant polycystic ovary syndrome
Author(s) -
Elkhayat Waleed,
Abdel Moety Ghada,
Al Mohammady Maged,
Hamed Dalia
Publication year - 2016
Publication title -
international journal of gynecology and obstetrics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.895
H-Index - 97
eISSN - 1879-3479
pISSN - 0020-7292
DOI - 10.1016/j.ijgo.2015.06.063
Subject(s) - clomifene , metformin , letrozole , medicine , polycystic ovary , pioglitazone , gynecology , randomized controlled trial , endocrinology , diabetes mellitus , type 2 diabetes , breast cancer , tamoxifen , cancer , insulin resistance
Objective To examine the efficacy of clomifene citrate, metformin, and pioglitazone versus letrozole, metformin, and pioglitazone among women with polycystic ovary syndrome (PCOS) resistant to clomifene citrate. Methods A prospective double‐blind randomized controlled trial of women younger than 40 years who had primary/secondary infertility associated with PCOS and had not ovulated in response to clomifene citrate regimens previously was conducted at a center in Cairo, Egypt, between August 1, 2013, and December 31, 2014. Computer‐generated random number tables and opaque envelopes were used to assign participants to group A or group B. Participants allocated to group A received 100 mg clomifene citrate daily for 5 days from the third day of the menstrual cycle, whereas those in group B received 5 mg letrozole daily in the same regimen. All patients received 850 mg metformin and 15 mg pioglitazone for 10 days from the first day of the menstrual cycle. The primary outcome was cumulative ovulation rate. Analyses were by intention to treat. Results Fifty women were assigned to each group. Ovulation occurred in 108 (92.3%) of 117 cycles in group A and 93 (86.9%) of 107 cycles in Group B ( P = 0.184). Conclusion Combined treatment with letrozole, metformin, and pioglitazone was efficacious among women with PCOS resistant to clomifene citrate. ClinicalTrials.gov: NCT01909141