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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Recruitment Status : Withdrawn (Recent findings suggest that letrozole may be a superior Clomiphene Citrate.)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

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.


Condition or disease Intervention/treatment Phase
Polycystic Ovary Syndrome Infertility Drug: Progestin Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Progestin-Induced Endometrial Shedding on Ovulation Induction Cycles With Clomiphene Citrate: A Randomized Study
Study Start Date : October 2013
Estimated Primary Completion Date : September 2015
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


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 Name: medroxyprogesterone acetate (MPA), i.e. Provera

No Intervention: Withdrawal Bleed
Progestin prior to beginning ovulation induction with clomiphene citrate (standard care)



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. cumulative pregnancy rate [ Time Frame: assessed 9 months after the ovulation induction cycles ]
    cumulative pregnancy rate

  2. ovulation rate [ Time Frame: assessed 1 month after each induced ovulation cycle ]
    ovulation rate (progesterone >10nmol/L per clomiphene cycle)

  3. 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)

  4. miscarriage rate [ Time Frame: Assessed 4 months after clinical pregnancy acheived ]
    miscarriage rate

  5. multiple pregnancy rate [ Time Frame: Assessed 4 months after clinical pregnancy acheived ]
    multiple pregnancy rate (twins and higher order multiples)

  6. endometrial thickness [ Time Frame: Assessed at 1 month after conception ]
    endometrial thickness (assessed via transvaginal ultrasound)



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Ages Eligible for Study:   18 Years to 38 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01966575


Locations
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Canada, British Columbia
Pacific Centre for Reproductive Medicine
Burnaby, British Columbia, Canada, V5G 4X7
Sponsors and Collaborators
University of British Columbia
Investigators
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Principal Investigator: Jon Havelock, MD University of British Columbia

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Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT01966575     History of Changes
Other Study ID Numbers: H13-02187
First Posted: October 21, 2013    Key Record Dates
Last Update Posted: November 6, 2014
Last Verified: November 2014

Keywords provided by University of British Columbia:
Polycystic ovary syndrome
Progestin
Endometrial shedding
Ovulation induction cycles
Clomiphene citrate
Clinical pregnancy rate

Additional relevant MeSH terms:
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Infertility
Polycystic Ovary Syndrome
Genital Diseases, Male
Genital Diseases, Female
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Gonadal Disorders
Endocrine System Diseases
Citric Acid
Sodium Citrate
Clomiphene
Enclomiphene
Zuclomiphene
Medroxyprogesterone
Medroxyprogesterone Acetate
Progestins
Anticoagulants
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Fertility Agents, Female
Fertility Agents