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

Overview

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.

Full Title of 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)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 2016

Detailed Description

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.

Interventions

  • Drug: Progestin
  • Drug: Clomiphene Citrate

Arms, Groups and Cohorts

  • Experimental: Group A (No PIES)
    • 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
  • 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) 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

Clinical Trial Outcome Measures

Primary Measures

  • Live Birth
    • Time Frame: Within 36 weeks of a positive pregnancy test
    • Delivery of a viable infant after 24 weeks of pregnancy

Participating in This Clinical Trial

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)

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 40 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Illinois at Chicago
  • Provider of Information About this Clinical Study
    • Principal Investigator: Albert Asante, MD MPH, Assistant Professor of Obstetrics-Gynecology, Consultant in Reproductive Endocrinology and Infertility – University of Illinois at Chicago
  • Overall Official(s)
    • Albert Asante, MD, MPH, Principal Investigator, University of Illinois at Chicago

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