Clinical trial NCT02340013: Endometrial Shedding Prior to Ovulation Induction Pilot Study
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Infertility
Lead sponsor: Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Sponsor class: OTHER
Collaborators: name: University of Toronto
First posted: 2015-01-16
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility 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.

Primary outcomes:
measure: Composite measure of study feasibility
timeFrame: 2 years
Secondary outcomes:
measure: pregnancy rate per ovulation
timeFrame: 2 years
measure: ovulation rate per cycle started,
timeFrame: 2 years
measure: conception rate per cycle started
timeFrame: 2 years
measure: conception rate per ovulation
timeFrame: 2 years
measure: time to complete 3 stimulation cycles
timeFrame: 2 years
measure: time to pregnancy
timeFrame: 2 years
measure: endometrial thickness at time of luteinizing hormone surge
timeFrame: 2 years
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: First Steps Fertility
state: Ontario
city: Toronto
country: Canada
facility: Mount Sinai Hospital
state: Ontario
Study officials:
affiliation: MOUNT SINAI HOSPITAL
name: Heather Shapiro, MD
role: PRINCIPAL_INVESTIGATOR
References: