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

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ClinicalTrials.gov Identifier: NCT01966575
Recruitment Status : Withdrawn (Recent findings suggest that letrozole may be a superior Clomiphene Citrate.)
First Posted : October 21, 2013
Last Update Posted : November 6, 2014
Sponsor:
Information provided by (Responsible Party):
University of British Columbia

Tracking Information
First Submitted Date  ICMJE September 17, 2013
First Posted Date  ICMJE October 21, 2013
Last Update Posted Date November 6, 2014
Study Start Date  ICMJE October 2013
Estimated Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 16, 2013)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 16, 2013)
  • cumulative pregnancy rate [ Time Frame: assessed 9 months after the ovulation induction cycles ]
    cumulative pregnancy rate
  • ovulation rate [ Time Frame: assessed 1 month after each induced ovulation cycle ]
    ovulation rate (progesterone >10nmol/L per clomiphene 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)
  • miscarriage rate [ Time Frame: Assessed 4 months after clinical pregnancy acheived ]
    miscarriage rate
  • multiple pregnancy rate [ Time Frame: Assessed 4 months after clinical pregnancy acheived ]
    multiple pregnancy rate (twins and higher order multiples)
  • endometrial thickness [ Time Frame: Assessed at 1 month after conception ]
    endometrial thickness (assessed via transvaginal ultrasound)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Progestin-Induced Withdrawal Bleed on Ovulation Induction Cycles With Clomiphene Citrate
Official Title  ICMJE Effect of Progestin-Induced Endometrial Shedding on Ovulation Induction Cycles With Clomiphene Citrate: A Randomized Study
Brief Summary

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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Polycystic Ovary Syndrome
  • Infertility
Intervention  ICMJE 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 Name: medroxyprogesterone acetate (MPA), i.e. Provera
Study Arms  ICMJE
  • Experimental: No withdrawal bleed
    No progestin prior to ovulation induction with clomiphene citrate
    Intervention: Drug: Progestin
  • No Intervention: Withdrawal Bleed
    Progestin prior to beginning ovulation induction with clomiphene citrate (standard care)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: November 4, 2014)
0
Original Estimated Enrollment  ICMJE
 (submitted: October 16, 2013)
154
Estimated Study Completion Date  ICMJE December 2015
Estimated Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 38 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01966575
Other Study ID Numbers  ICMJE H13-02187
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of British Columbia
Study Sponsor  ICMJE University of British Columbia
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jon Havelock, MD University of British Columbia
PRS Account University of British Columbia
Verification Date November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP