Endometrial Shedding Prior to Ovulation Induction Pilot Study

NCT02340013 | Completed Phase 4

• 1 other identifier: 2014-01
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

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.

Conditions

Infertility

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• 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

Study Arms (2)

Medroxyprogesterone acetate

ACTIVE COMPARATOR

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

Control

NO INTERVENTION

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

Interventions

Medroxyprogesterone acetate 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.

Also known as: Provera

Medroxyprogesterone acetate

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Samuel Lunenfeld Research Institute, Mount Sinai Hospital: lead
• University of Toronto: collaborator

Study Sites (2)

First Steps Fertility

Toronto, Ontario, M2P 2E3, Canada

Location

Mount Sinai Hospital

Toronto, Ontario, M5T 2Z5, Canada

Location

MeSH Terms

Conditions

Infertility

Interventions

Medroxyprogesterone Acetate

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Medroxyprogesterone; Hydroxyprogesterones; Progesterone; Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Heather Shapiro, MD

  MOUNT SINAI HOSPITAL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2014
• First Posted: January 16, 2015
• Study Start: July 1, 2013
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: November 13, 2015

Record last verified: 2015-11

Locations

CA (2)