Progestin-induced Endometrial Shedding in PCOS (The PIES in PCOS Study)
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.
Polycystic Ovary Syndrome
Drug: Clomiphene Citrate
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Optimizing Fertility Treatment in Women With Polycystic Ovary Syndrome (PCOS) - A Randomized Controlled Trial: The Role of Progestin-induced Endometrial Shedding in PCOS (PIES in PCOS)|
- Live birth [ Time Frame: Within 36 weeks of a positive pregnancy test ] [ Designated as safety issue: No ]Delivery of a viable infant after 24 weeks of pregnancy
- Time to first ovulation [ Time Frame: Within 3 months of start of CC ] [ Designated as safety issue: No ]
- Time to clinical pregnancy [ Time Frame: Within 6 months of start of CC ] [ Designated as safety issue: No ]
- Clinical pregnancy rate [ Time Frame: Within 3 weeks of a positive pregnancy test ] [ Designated as safety issue: No ]
- Miscarriage rate [ Time Frame: Within 20 weeks of pregnancy ] [ Designated as safety issue: No ]
|Study Start Date:||March 2015|
|Estimated Study Completion Date:||January 2018|
|Estimated Primary Completion Date:||March 2017 (Final data collection date for primary outcome measure)|
Experimental: Group A (No PIES)
Subjects randomized to this group will receive clomiphene citrate (CC) without using progestin throughout their treatment course.
Drug: Clomiphene Citrate
Active Comparator: Group B (PIES Group)
Women randomized to this group will receive progestin to induce endometrial shedding before starting any doses of clomiphene citrate (CC)
Other Names:Drug: Clomiphene Citrate
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01718444
|Contact: Albert Asante, MD, MPHfirstname.lastname@example.org|
|Contact: Eve Hardin, RNemail@example.com|
|United States, Illinois|
|University of Illinois at Chicago||Recruiting|
|Chicago, Illinois, United States, 60612|
|Contact: Albert Asante, MD, MPH 312-355-4983 firstname.lastname@example.org|
|Principal Investigator: Albert Asante, MD, MPH|
|Sub-Investigator: Musa Zamah, MD, PhD|
|Sub-Investigator: Mary Stephenson, MD, MSc|
|Sub-Investigator: Humberto Scoccia, MD|
|Principal Investigator:||Albert Asante, MD, MPH||University of Illinois at Chicago|