Progestin-induced Endometrial Shedding in PCOS (The PIES in PCOS Study) (NCT01718444) | Clinical Trial Compass
TerminatedNot Applicable
Progestin-induced Endometrial Shedding in PCOS (The PIES in PCOS Study)
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.
United States27 participantsStarted 2015-03
Plain-language 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.
Who can participate
Age range
18 Years – 40 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion
* Women aged 18 - 40, desiring pregnancy
* Established diagnosis of PCOS confirmed by the Rotterdam criteria
* Oligo or anovulatory, with menstrual cycles \> 35 days apart or less than 9 menstrual cycles per year
* Normal vaginal ultrasound with endometrial stripe \< 12 mm
* Normal thyroid stimulating hormone (TSH) within past one year
* Normal prolactin (PRL) within past one year
* For women with previous successful Clomid treatment, a washout period of at least 2 months is required
Exclusion
* Regular menstrual cycles occurring less than 35 days apart
* Evidence of other infertility factors such as endometriosis, tubal factor or male infertility
* Prior unsuccessful Clomiphene citrate ovulation cycles
* Abnormal vaginal ultrasound findings such as endometrial polyps, submucous myomas, synechiae
* Uterine anomaly such as unicornuate or bicornuate uterus
* Presence of hydrosalpinx
* Evidence of active endocrinopathy, such as thyroid disorder or hyperprolactinemia
* Partner with abnormal semen analysis (count \< 15 million sperm /ml)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Live Birth
Timeframe: Within 36 weeks of a positive pregnancy test