Endometrial Shedding Prior to Ovulation Induction Pilot Study

• Status: Completed
• Trial end date: 2015-04-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Samuel Lunenfeld Research Institute, Mount Sinai Hospital
• Collaborator: University of Toronto
• Treatments: Citric Acid; Clomiphene; Enclomiphene; Medroxyprogesterone; Medroxyprogesterone Acetate; Zuclomiphene

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.