drugset / Trial / NCT01718444

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

NCT01718444 ↗

Terminated 27 enrolled University of Illinois at Chicago
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2015-03
Primary completion
2016-06
Completion
2016-06

Outcome

Outcome not reported

Stopped: “The primary investigator moved from academic practice to join a private group, and could not get any one to take over as PI for the study.”

Drugs

EvaluationDrugModalityDoseRoute
Subject Clomiphene Citrate Other / unclassified 50 mg Oral
Subject Clomiphene Citrate Other / unclassified 100 mg Oral
Subject Clomiphene Citrate Other / unclassified 150 mg Oral
Comparator medroxyprogesterone acetate Other / unclassified 10 mg Oral