Clinical trial · Interventional
Progestin-induced Endometrial Shedding in PCOS (The PIES in PCOS Study)
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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): 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.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Infertility | — | UNRESOLVED | — |
| Polycystic Ovary Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Clomiphene Citrate | Drug | — | UNRESOLVED |
| Progestin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Group A (No PIES)
- description
- 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
- interventionNames
- Drug: Clomiphene Citrate
- type
- ACTIVE_COMPARATOR
- label
- Group B (PIES Group)
- description
- 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
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 40 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available