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

Phase 4

Withdrawn

• Conditions: Infertility; Polycystic Ovary Syndrome
• Interventions: Drug: Progestin

• Registration Number: NCT01966575
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-09-17
• Study Start: 2013-10
• Study First Submitted QC: 2013-10-16
• Study First Posted: 2013-10-21
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-04
• Last Update Posted: 2014-11-06
• Primary Completion: 2015-09
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
No withdrawal bleed	Progestin	No progestin prior to ovulation induction with clomiphene citrate

Primary Outcome Measures

Name	Time	Method
Clinical pregnancy rate per ovulation	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

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

Trial Locations

Locations (1)

Pacific Centre for Reproductive Medicine; 🇨🇦 Burnaby, British Columbia, Canada