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

September 8, 2020 updated by: Albert Asante, MD MPH, University of Illinois at Chicago

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)

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

27

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60612
        • University of Illinois at Chicago

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Drug: Clomiphene Citrate
Other Names:
  • Clomid
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
Drug: Clomiphene Citrate
Other Names:
  • Clomid
Drug: Progestin
Other Names:
  • Provera
  • Medroxyprogesterone acetate

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Illinois at Chicago

Investigators

  • Principal Investigator: Albert Asante, MD, MPH, University of Illinois at Chicago

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (ACTUAL)

June 1, 2016

Study Completion (ACTUAL)

June 1, 2016

Study Registration Dates

First Submitted

October 19, 2012

First Submitted That Met QC Criteria

October 29, 2012

First Posted (ESTIMATE)

October 31, 2012

Study Record Updates

Last Update Posted (ACTUAL)

September 29, 2020

Last Update Submitted That Met QC Criteria

September 8, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014-1070

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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