This study evaluates the addition of clomid to letrozole for the treatment of infertility in women with polycystic ovary syndrome. Half of the participants will receive letrozole and clomid in combination, while the other half will receive letrozole alone.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
70
University of Iowa Hospitals & Clinics
Iowa City, Iowa, United States
Number of Participants Achieving Ovulation Measured by Mid-luteal Progesterone Level
Ovulation: mid-luteal progesterone \> /=3 ng/mL. No ovulation: mid-luteal progesterone \<3ng/mL.
Time frame: 7 days following LH surge or at cycle day 21 if no LH surge was detected
Number of Developing Follicles
Number of follicles measuring \> 10mm on ultrasound
Time frame: Cycle day 12-14
Size of Largest Developing Follicle
Size of largest follicle on ultrasound
Time frame: Cycle day 12-14
Endometrial Thickness
Thickness of endometrial lining assessed by ultrasound
Time frame: Cycle day 12-14
Conception
Conception: a positive serum or urinary test of hCG; No conception: Neither a positive serum or urinary test of hCG
Time frame: 5 weeks after treatment
Clinical Pregnancy
Clinical Pregnancy: an intrauterine pregnancy with fetal heart motion determined by ultrasonography; No Clinical Pregnancy: no intrauterine pregnancy with fetal heart motion determined by ultrasonography
Time frame: 6-7 weeks after treatment
Multiple Gestation
Multiple Gestation: an intrauterine pregnancy with multiple fetal heart rates determined by ultrasonography; No Multiple Gestation: either no intrauterine pregnancy, or an intrauterine pregnancy with a single fetal heart rate determined by ultrasonography
Time frame: 9-10 months after treatment
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Live Birth
Live Birth: delivery of a live infant; No Live Birth: no delivery of a live infant
Time frame: 9-10 months after treatment
Pregnancy Loss
Pregnancy Loss: any pregnancy loss including biochemical pregnancy, ectopic pregnancy, and miscarriage; No Pregnancy Loss: no pregnancy loss including biochemical pregnancy, ectopic pregnancy, or miscarriage.
Time frame: 9-10 months after treatment