Endometrial Shedding Prior to Ovulation Induction Pilot Study

Samuel Lunenfeld Research Institute, Mount Sinai Hospital50 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Infertility

Interventions

Medroxyprogesterone acetateDRUG

Women in this arm of the study will be assigned to start medroxyprogesterone acetate 10mg per os x 10 days. This will be followed by vaginal bleeding. On the 3rd day of vaginal bleeding, women will start clomiphene citrate 50mg per os x 5 days for ovulation induction.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (2)

First Steps Fertility

Toronto, Ontario, Canada

Mount Sinai Hospital

Toronto, Ontario, Canada

Outcomes

Primary Outcomes

Composite measure of study feasibility

Time to recruit 50 patients; physician, nursing and patient compliance rate with the study protocol; and patient satisfaction.

Time frame: 2 years

Secondary Outcomes

pregnancy rate per ovulation

Time frame: 2 years

ovulation rate per cycle started,

Time frame: 2 years

conception rate per cycle started

Time frame: 2 years

conception rate per ovulation

Time frame: 2 years

time to complete 3 stimulation cycles

Time frame: 2 years

time to pregnancy

Time frame: 2 years

endometrial thickness at time of luteinizing hormone surge

Time frame: 2 years

Data from ClinicalTrials.gov

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