Clomiphene Citrate Fast-Track Protocol for Fertility Treatment in Women With PCOS
Women with polycystic ovary syndrome (PCOS) have traditionally been treated for infertility by using progestin for a withdrawal bleed (aka endometrial shedding) before clomiphene citrate (CC) is administered to induce ovulation.
Recent evidence suggests that this approach (the traditional CC protocol) may be associated with decreased pregnancy and live birth rates, compared to the "fast track" CC protocol (in which no progestin is used).
The investigators are performing the first randomized controlled trial to find out if skipping the use of progestin (fast track CC protocol) during fertility therapy of anovulatory PCOS women leads to improved pregnancy and live birth rates compared to the traditional CC protocol.
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) Using the Clomiphene Citrate Fast-Track Protocol: a Randomized Controlled Trial|
- Clinical pregnancy confirmed by pelvic ultrasound [ Time Frame: Within 3 weeks of a positive pregnancy test ] [ Designated as safety issue: No ]
- 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 ]
- Live birth [ Time Frame: Delivery after 24 weeks of pregnancy ] [ Designated as safety issue: No ]
|Study Start Date:||October 2012|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
Experimental: Clomiphene Citrate Fast-Track Protocol
Subjects randomized to this group will be managed using the Clomiphene Citrate (Clomid) fast-track protocol and will receive Clomid without using Progestin throughout their treatment course.
Drug: Clomiphene Citrate
Active Comparator: Traditional Clomiphene Citrate Protocol
Women randomized to this group will receive Clomiphene Citrate (Clomid) using a traditional incremental-dose protocol, with Progestin given to induce a withdrawal bleed before starting any doses of Clomid.
Other Name: ProveraDrug: Clomiphene Citrate
Please refer to this study by its ClinicalTrials.gov identifier: NCT01718444
|United States, Minnesota|
|Mayo Clinic in Rochester|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Jani Jensen, MD||Mayo Clinic|