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

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: September 2015

Interventions

  • 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.

Arms, Groups and Cohorts

  • Experimental: No withdrawal bleed
    • No progestin prior to ovulation induction with clomiphene citrate
  • No Intervention: Withdrawal Bleed
    • Progestin prior to beginning ovulation induction with clomiphene citrate (standard care)

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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)

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 38 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of British Columbia
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Jon Havelock, MD, Principal Investigator, University of British Columbia

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