Progestin-induced Endometrial Shedding in PCOS (The PIES in PCOS Study)

Not Applicable

Terminated

Conditions: Polycystic Ovary Syndrome
Infertility

Interventions: Drug: Progestin
Drug: Clomiphene Citrate

Registration Number: NCT01718444

Lead Sponsor: University of Illinois at Chicago

Brief Summary: Progestin-induced endometrial shedding (PIES) followed by clomiphene citrate is fertility treatment of choice in anovulatory women with polycystic ovary syndrome (PCOS). However, some preliminary data suggest that skipping PIES could result in a higher live birth rate. The investigators are performing the first randomized controlled trial to find out if skipping the use of progestin during fertility treatment of anovulatory PCOS women is associated with improved pregnancy and live birth rates compared to the traditional approach of using progestin prior to use of clomiphene citrate.

Detailed Description: This is a prospective randomized trial of clomiphene citrate (CC) preceded by progestin-induced endometrial shedding (PIES) vs CC without PIES in the treatment of infertility in patients with PCOS, for up to 5 treatment cycles.

Participants will be randomized to receive either progestin followed by CC starting on day 3 of the induced menses, or CC without induced menses. Study participants will be monitored at regular 2 to 4 wks intervals for response to medication using ultrasound and hormonal parameters. The maximum dose of CC will not exceed 750 mg/cycle. Treatment will not exceed 5 ovulatory cycles. Participants who are resistant to 150 mg of CC will exit the study.

170 anovulatory PCOS women actively seeking pregnancy, aged 18 through 40 years will be enrolled and randomized in a 1:1 treatment ratio into the two study arms. Anovulation will be the only infertility factor in all patients.

Recruitment & Eligibility

Status: TERMINATED

Sex: Female

Target Recruitment: 27

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group B (PIES Group)	Progestin	Women randomized to this group will receive progestin to induce endometrial shedding before starting any doses of clomiphene citrate (CC) * Progestin 10 mg oral for 10 days to induce endometrial shedding (PIES) * CC 50 mg oral for 5 days (Day 3-7) * If no ovulation, progestin 10 mg for 10 days to induce endometrial shedding (starting on CD28) and CC 100 mg x 5 days, starting on day 3 of induced menses * If no ovulation, progestin 10 mg for 10 days to induce endometrial shedding, and CC 150 mg for 5 days * Exit study if no response to 150 mg CC, or if no pregnancy after 5 ovulatory cycles
Group A (No PIES)	Clomiphene Citrate	Subjects randomized to this group will receive clomiphene citrate (CC) without using progestin throughout their treatment course. * CC 50 mg oral for 5 days ("Days 3-7") * If no ovulation, CC 100 mg for 5 days ("Days 12-16") * If no ovulation, CC 150 mg for 5 days ("Day 21-25") * Exit study if no response to 150 mg CC, or if no pregnancy after 5 ovulatory cycles
Group B (PIES Group)	Clomiphene Citrate	Women randomized to this group will receive progestin to induce endometrial shedding before starting any doses of clomiphene citrate (CC) * Progestin 10 mg oral for 10 days to induce endometrial shedding (PIES) * CC 50 mg oral for 5 days (Day 3-7) * If no ovulation, progestin 10 mg for 10 days to induce endometrial shedding (starting on CD28) and CC 100 mg x 5 days, starting on day 3 of induced menses * If no ovulation, progestin 10 mg for 10 days to induce endometrial shedding, and CC 150 mg for 5 days * Exit study if no response to 150 mg CC, or if no pregnancy after 5 ovulatory cycles

Primary Outcome Measures