Endometrial Shedding Prior to Ovulation Induction Pilot Study

Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Status and phase: Completed; Phase 4

Conditions: Infertility

Treatments: Drug: Medroxyprogesterone acetate

Study type: Interventional

Funder types: Other

Identifiers

NCT02340013

2014-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups

Medroxyprogesterone acetate

Active Comparator group

Description:

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

Treatment:

Drug: Medroxyprogesterone acetate

Control

No Intervention group

Description:

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