Endometrial Shedding Prior to Ovulation Induction Pilot Study

NCT ID: NCT02340013

Last Updated: 2015-11-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-07-31
• Study Completion Date: 2015-04-30

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.

Conditions

Infertility

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

Medroxyprogesterone acetate

Intervention Type: DRUG

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.

Control

Women are assigned to start clomiphene citrate 50mg tabs x 5 days on an assigned day, without any vaginal bleeding

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Provera

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Toronto

OTHER

Sponsor Role: collaborator

Samuel Lunenfeld Research Institute, Mount Sinai Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Heather Shapiro, MD

Role: PRINCIPAL_INVESTIGATOR

MOUNT SINAI HOSPITAL

Locations

First Steps Fertility

Toronto, Ontario, Canada

Mount Sinai Hospital

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

2014-01

Identifier Type: -

Identifier Source: org_study_id