Endometrial Shedding Prior to Ovulation Induction Pilot Study

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Infertility

Intervention / Treatment
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* Drug: Medroxyprogesterone acetate


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Medroxyprogesterone acetate<br>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<br>* 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.<br>* Other names: Provera;|
| No Intervention: Control<br>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?
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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 | Measure Description | 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 |