Endometrial Shedding Prior to Ovulation Induction Pilot Study

The Effect of Endometrial Shedding With Medroxyprogesterone Acetate Prior to Ovulation Induction With Clomiphene Citrate in Oligo-ovulatory and Anovulatory Women: a Pilot Study

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.

Study Overview

• Status: Completed
• Conditions: Infertility
• Intervention / Treatment: Drug: Medroxyprogesterone acetate

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 Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 4

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M2P 2E3
      • First Steps Fertility
    • Toronto, Ontario, Canada, M5T 2Z5
      • Mount Sinai Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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	Drug: Medroxyprogesterone acetate; 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.; Other Names: Provera
No Intervention: Control; Women are assigned to start clomiphene citrate 50mg tabs x 5 days on an assigned day, without any vaginal bleeding

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Samuel Lunenfeld Research Institute, Mount Sinai Hospital
• Collaborators: University of Toronto
• Investigators: Principal Investigator: Heather Shapiro, MD, Mount Sinai Hospital

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (Actual): April 1, 2015
• Study Completion (Actual): April 1, 2015

Study Registration Dates

• First Submitted: December 12, 2014
• First Submitted That Met QC Criteria: January 12, 2015
• First Posted (Estimate): January 16, 2015

Study Record Updates

• Last Update Posted (Estimate): November 13, 2015
• Last Update Submitted That Met QC Criteria: November 11, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infertility; Physiological Effects of Drugs; Antineoplastic Agents; Antineoplastic Agents, Hormonal; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Contraceptives, Oral; Contraceptive Agents, Female; Contraceptives, Oral, Synthetic; Contraceptives, Oral, Hormonal; Contraceptive Agents, Male; Medroxyprogesterone Acetate; Medroxyprogesterone
• Other Study ID Numbers: 2014-01