Effect of Progestin-Induced Withdrawal Bleed on Ovulation Induction Cycles With Clomiphene Citrate

November 4, 2014 updated by: University of British Columbia

Effect of Progestin-Induced Endometrial Shedding on Ovulation Induction Cycles With Clomiphene Citrate: A Randomized Study

Women with polycystic ovary syndrome (PCOS) can suffer from infertility because they do not produce an egg each month, resulting in irregular periods. As a result, these women often need a medication called clomiphene citrate (clomiphene) to induce ovulation. A traditional 'clomiphene protocol' begins with a short course of progestin treatment to bring on a period (termed a 'withdrawal bleed') before starting the clomiphene medication. Newer evidence, however, has suggested that this progestin-induced shedding of the uterine lining (i.e., withdrawal bleed) may decrease the chances of pregnancy. The purpose of our study is to determine whether withdrawal bleeding has an impact on pregnancy rates for patients with PCOS undergoing a clomiphene cycle.

It is hypothesized that patients who undergo ovulation induction with clomiphene citrate without prior endometrial shedding will have higher clinical pregnancy rates than those who begin with a progestin-induced withdrawal bleed.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 4

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

  • Canada
    • British Columbia
      • Burnaby, British Columbia, Canada, V5G 4X7
        • Pacific Centre for Reproductive Medicine

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

16 years to 36 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Polycystic ovary syndrome (Rotterdam 2003 Consensus Criteria) and a diagnosis of anovulatory infertility
  • Age 18-38 years
  • At least 1 patent fallopian tube (as demonstrated by hysterosalpingogram, hydrotubation or hysterosonogram within the last year)
  • Normal semen analysis (total motile sperm count >20million/ml)
  • Normal uterine cavity (as demonstrated by hysterosalpingogram, hydrotubation or hysterosonogram within the last year)
  • Undergoing ovulation-induction with clomiphene citrate without intra-uterine insemination (IUI)

Exclusion Criteria:

  • Body mass index (BMI) < 17 kg/m2 or > 40 kg/m2
  • Prior treatment with clomiphene citrate
  • Presence of a hydrosalpinx (as seen on ultrasound, hysterosalpingogram, hydrotubation or hysterosonogram)
  • Those with systemic disease such as diabetes mellitus, uncontrolled thyroid disease, systemic lupus erythematosus and antiphospholipid antibody syndrome
  • Any other cause of infertility other than anovulation

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 Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: No withdrawal bleed
No progestin prior to ovulation induction with clomiphene citrate
Drug: Progestin
The experimental group will have no progestin prior to ovulation induction with clomiphene citrate, while the comparison group will have progestin medication prior to ovulation induction with clomiphene citrate, as per usual care.
Other Names:
  • medroxyprogesterone acetate (MPA), i.e. Provera
No Intervention: Withdrawal Bleed
Progestin prior to beginning ovulation induction with clomiphene citrate (standard care)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical pregnancy rate per ovulation
Time Frame: 6 weeks after starting clomiphene
clinical pregnancy rate (gestational sac seen on ultrasound approximately 6-7 weeks after starting clomiphene) per ovulation
6 weeks after starting clomiphene

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
cumulative pregnancy rate
Time Frame: assessed 9 months after the ovulation induction cycles
cumulative pregnancy rate
assessed 9 months after the ovulation induction cycles
ovulation rate
Time Frame: assessed 1 month after each induced ovulation cycle
ovulation rate (progesterone >10nmol/L per clomiphene cycle)
assessed 1 month after each induced ovulation cycle
ongoing pregnancy rate
Time Frame: assessed 12 weeks after clinical pregnancy is acheived
ongoing pregnancy rate (pregnancy with a fetal heartbeat >12 weeks gestational age)
assessed 12 weeks after clinical pregnancy is acheived
miscarriage rate
Time Frame: Assessed 4 months after clinical pregnancy acheived
miscarriage rate
Assessed 4 months after clinical pregnancy acheived
multiple pregnancy rate
Time Frame: Assessed 4 months after clinical pregnancy acheived
multiple pregnancy rate (twins and higher order multiples)
Assessed 4 months after clinical pregnancy acheived
endometrial thickness
Time Frame: Assessed at 1 month after conception
endometrial thickness (assessed via transvaginal ultrasound)
Assessed at 1 month after conception

Collaborators and Investigators

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

Sponsor

University of British Columbia

Investigators

  • Principal Investigator: Jon Havelock, MD, University of British Columbia

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

October 1, 2013

Primary Completion (Anticipated)

September 1, 2015

Study Completion (Anticipated)

December 1, 2015

Study Registration Dates

First Submitted

September 17, 2013

First Submitted That Met QC Criteria

October 16, 2013

First Posted (Estimate)

October 21, 2013

Study Record Updates

Last Update Posted (Estimate)

November 6, 2014

Last Update Submitted That Met QC Criteria

November 4, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H13-02187

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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