Endometrial Shedding Prior to Ovulation Induction Pilot Study

Infertility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02340013
• Other study ID #: 2014-01
• Status: Completed
• Phase: Phase 4
• First received: December 12, 2014
• Last updated: November 11, 2015
• Start date: July 2013
• Est. completion date: April 2015

Study information

• Verified date: November 2015
• Source: Samuel Lunenfeld Research Institute, Mount Sinai Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infertility

Intervention

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.

Locations

Country	Name	City	State
Canada	First Steps Fertility	Toronto	Ontario
Canada	Mount Sinai Hospital	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Samuel Lunenfeld Research Institute, Mount Sinai Hospital	University of Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	pregnancy rate per ovulation		2 years	No
Secondary	ovulation rate per cycle started,		2 years	No
Secondary	conception rate per cycle started		2 years	No
Secondary	conception rate per ovulation		2 years	No
Secondary	time to complete 3 stimulation cycles		2 years	No
Secondary	time to pregnancy		2 years	No
Secondary	endometrial thickness at time of luteinizing hormone surge		2 years	No