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| Name | Class |
|---|---|
| University of Toronto | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Control | No Intervention | Women are assigned to start clomiphene citrate 50mg tabs x 5 days on an assigned day, without any vaginal bleeding |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| pregnancy rate per ovulation | 2 years | |
| ovulation rate per cycle started, | 2 years | |
| conception rate per cycle started |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Heather Shapiro, MD | MOUNT SINAI HOSPITAL | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First Steps Fertility | Toronto | Ontario | M2P 2E3 | Canada | ||
| Mount Sinai Hospital |
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| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D017258 | Medroxyprogesterone Acetate |
| ID | Term |
|---|---|
| D008525 | Medroxyprogesterone |
| D006908 | Hydroxyprogesterones |
| D011374 | Progesterone |
| D011282 | Pregnenediones |
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|
| 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 |
| Toronto |
| Ontario |
| M5T 2Z5 |
| Canada |
| D011283 |
| Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |