Combined Letrozole and Clomid in Women With Infertility and PCOS
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|ClinicalTrials.gov Identifier: NCT02802865|
Recruitment Status : Completed
First Posted : June 16, 2016
Last Update Posted : April 16, 2019
|Condition or disease||Intervention/treatment||Phase|
|Polycystic Ovary Syndrome Infertility||Drug: Clomiphene Drug: Letrozole||Phase 4|
Letrozole and Clomid are both used for ovulation induction, but they have different mechanisms of action. Letrozole has been shown to be superior to clomid in achieving live birth rates in women with infertility and polycystic ovary syndrome. However, the combination of these medications has not been studied. This is a pilot study to evaluate if the combination treatment has improved efficacy as measured by ovulation rate.
This is a randomized controlled trial of letrozole versus letrozole and clomiphene citrate (CC) for one menstrual cycle. Women will be randomized in a 1:1 ratio to receive letrozole 2.5 mg or combination of letrozole 2.5 mg and clomiphene 50 mg for 5 days on days 3-7 of menstrual cycle. The women and their partners will be instructed to have regular intercourse with the intent to conceive during the cycle. Patients will have an transvaginal ultrasound mid cycle and to evaluate number of follicles (>15 mm), follicle size, endometrial thickness and pattern. Patients will have mid- luteal phase progesterone level drawn to evaluate ovulation. Side effect profile will also be monitored.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||70 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Combined Letrozole and Clomid in Polycystic Ovary Syndrome: a Randomized Control Trial of Combination of Letrozole and Clomiphene Citrate or Letrozole Alone for the Treatment of Infertility in Women With Polycystic Ovary Syndrome|
|Study Start Date :||August 2016|
|Actual Primary Completion Date :||May 2018|
|Actual Study Completion Date :||February 2019|
Active Comparator: Letrozole
Letrozole 2.5 mg orally for 5 days on cycle days 3-7
Other Name: femara
Experimental: Letrozole + Clomiphene
Letrozole 2.5 mg orally for 5 days on cycle days 3-7 AND Clomid 50 mg orally for 5 days on cycle days 3-7
Other Name: femara
- Number of participants achieving ovulation measured by mid-luteal progesterone level [ Time Frame: 7 days following LH surge or at cycle day 21 if no LH surge was detected ]Ovulation: mid-luteal progesterone > /=3 ng/mL. No ovulation: mid-luteal progesterone <3ng/mL.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02802865
|United States, Iowa|
|University of Iowa Hospitals & Clinics|
|Iowa City, Iowa, United States, 52242|
|Principal Investigator:||Rachel Mejia, DO||University of Iowa Hosptials & Clinics|
|Principal Investigator:||Brad Van Voorhis, MD||University of Iowa Hospitals & Clinics|