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

Primary Purpose

Polycystic Ovary Syndrome, Infertility

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Progestin
Clomiphene Citrate
Sponsored by
University of Illinois at Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Polycystic Ovary Syndrome focused on measuring PCOS, Polycystic ovary syndrome, Infertility, Anovulation, Clomiphene citrate, Clomid, Progestin, Provera, Progesterone, Endometrial shedding

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

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)

Sites / Locations

  • University of Illinois at Chicago

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group A (No PIES)

Group B (PIES Group)

Arm 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

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

Outcomes

Primary Outcome Measures

Live Birth
Delivery of a viable infant after 24 weeks of pregnancy

Secondary Outcome Measures

Full Information

First Posted
October 19, 2012
Last Updated
September 8, 2020
Sponsor
University of Illinois at Chicago
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1. Study Identification

Unique Protocol Identification Number
NCT01718444
Brief Title
Progestin-induced Endometrial Shedding in PCOS (The PIES in PCOS Study)
Official Title
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
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Terminated
Why 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.
Study Start Date
March 2015 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Illinois at Chicago

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Ovary Syndrome, Infertility
Keywords
PCOS, Polycystic ovary syndrome, Infertility, Anovulation, Clomiphene citrate, Clomid, Progestin, Provera, Progesterone, Endometrial shedding

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A (No PIES)
Arm Type
Experimental
Arm 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
Arm Title
Group B (PIES Group)
Arm Type
Active Comparator
Arm 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
Intervention Type
Drug
Intervention Name(s)
Progestin
Other Intervention Name(s)
Provera, Medroxyprogesterone acetate
Intervention Type
Drug
Intervention Name(s)
Clomiphene Citrate
Other Intervention Name(s)
Clomid
Primary Outcome Measure Information:
Title
Live Birth
Description
Delivery of a viable infant after 24 weeks of pregnancy
Time Frame
Within 36 weeks of a positive pregnancy test

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Albert Asante, MD, MPH
Organizational Affiliation
University of Illinois at Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Illinois at Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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