Endometrial Shedding Prior to Ovulation Induction Pilot Study

Phase 4

Completed

• Conditions: Infertility
• Interventions: Drug: Medroxyprogesterone acetate

• Registration Number: NCT02340013
• Lead Sponsor: Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Brief Summary

This is a pilot study examining the feasibility of implementing a large randomized control trial looking at the effect of endometrial shedding with medroxyprogesterone acetate compared to no pre-treatment in women taking clomiphene citrate for ovulation induction for infertility due to oligo-ovulation or anovulation.

Detailed Description

The purpose of this pilot study is to assess the feasibility of implementing a randomized controlled trial assessing the effect of giving medroxyprogesterone acetate (MPA) to induce a withdrawal bleed compared to a control group of women not receiving MPA on pregnancy rates prior to ovulation induction with clomiphene citrate in oligo-ovulatory and anovulatory women. The primary outcome measure is the effective implementation of the study including a measure of time to recruit 50 patients, physician, nursing and patient compliance rate with the study protocol, and patient satisfaction. Secondary outcome measures include the pregnancy rate per ovulation (where pregnancy is defined as a positive fetal heart rate on ultrasound 2 weeks after a positive pregnancy test), the ovulation rate per cycle started, conception rate per cycle started (where conception is defined as a positive beta-human chorionic gonadotropin level), conception rate per ovulation, time to complete 3 stimulation cycles and endometrial thickness at time of luteinizing hormone surge.

Study Timeline

• Study Start: 2013-07
• Study First Submitted: 2014-12-12
• Study First Submitted QC: 2015-01-12
• Study First Posted: 2015-01-16
• Primary Completion: 2015-04
• Study Completion: 2015-04
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-11
• Last Update Posted: 2015-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 50

Inclusion Criteria

• Oligo-ovulation defined as having less than or equal to 8 menstrual cycles in the past year or inter-menstrual periods of 45 days or longer
• general good health
• ability to have timed intercourse or intrauterine insemination
• no evidence of tubal dysfunction
• no evidence of a uterine cavity abnormality
• no evidence of male factor infertility

Exclusion Criteria

• a baseline ultrasound showing an endometrial lining greater than 1.0 cm
• a baseline ultrasound showing an endometrial lining of less than 0.5 cm
• a positive progesterone level at baseline bloodwork
• a positive beta human chorionic gonadotropin level at baseline bloodwork
• body mass index of greater than 40
• women who have previously taken clomiphene citrate for ovulation induction within the last 6 months
• women who are taking metformin
• women who are taking a progestin for luteal phase support.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Medroxyprogesterone acetate	Medroxyprogesterone acetate	Medroxyprogesterone acetate 10mg per os x 10 days prior to starting clomiphene citrate 50mg once daily days 3 - 7 of bleeding after stopping medroxyprogesterone acetate

Primary Outcome Measures

Name	Time	Method
Composite measure of study feasibility	2 years	Time to recruit 50 patients; physician, nursing and patient compliance rate with the study protocol; and patient satisfaction.

Secondary Outcome Measures

Name	Time	Method
pregnancy rate per ovulation	2 years
ovulation rate per cycle started,	2 years
conception rate per cycle started	2 years
conception rate per ovulation	2 years
time to complete 3 stimulation cycles	2 years
time to pregnancy	2 years
endometrial thickness at time of luteinizing hormone surge	2 years

Trial Locations

Locations (2)

First Steps Fertility; 🇨🇦 Toronto, Ontario, Canada

Mount Sinai Hospital; 🇨🇦 Toronto, Ontario, Canada