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

NCT ID: NCT01966575

Last Updated: 2014-11-06

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2015-12-31

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.

Conditions

Polycystic Ovary Syndrome; Infertility

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

No withdrawal bleed

No progestin prior to ovulation induction with clomiphene citrate

Group Type: EXPERIMENTAL

Progestin

Intervention Type: DRUG

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.

Withdrawal Bleed

Progestin prior to beginning ovulation induction with clomiphene citrate (standard care)

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

medroxyprogesterone acetate (MPA), i.e. Provera

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 38 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of British Columbia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jon Havelock, MD

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Locations

Pacific Centre for Reproductive Medicine

Burnaby, British Columbia, Canada

Countries

Canada

Other Identifiers

H13-02187

Identifier Type: -

Identifier Source: org_study_id