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Up to half of all cases of recurrent pregnancy loss are unexplained (uRPL). Evidence points towards endometriosis and progesterone resistance as an underlying cause of uRPL. Previous non-RCT studies have suggested the luteal hCG provides a useful treatment for uRPL. We propose performing a randomized controlled trial to compare mid-luteal hCG with oral progesterone to prevent early pregnancy losses. the endpoint will be ongoing pregnancy and live birth rates. Equal numbers of patients will be randomized to each group.
Fifty (50) patients with unexplained recurrent pregnancy loss, defined as 2 or more losses. Workup will exclude structural, genetic, hormonal, and anti-phospholipid syndrome-related causes of RPL. Women with unexplained RPL will be randomized to receive a mid-luteal injection of ovidril (250 ug) 1 week after ovulation vs prometrium (200 mg qhs) starting 4 days after ovulation. If pregnant, prometrium will be continued until 8 weeks of pregnancy. If pregnancy does not occur, subjects will be allowed to repeat this protocol for up to 3 cycles. Outcomes will be listed as "not pregnant", "biochemical pregnancy", "miscarriage" or "ongoing pregnancy" for each cycle. Endpoints of pregnant cycles will be compared for pregnancy rate, miscarriage rate, ongoing pregnancy rate and live birth rate.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Progesterone | Active Comparator | Women receive prometrium 200 mg qhs for up to 8 weeks |
|
| hCG | Active Comparator | A single shot of hCG (ovidril 250 ug) will be given as a subcutaneous injection 1 week after ovulation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Progesterone Pill | Drug | Orally active progesterone |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Miscarriage | Loss of pregnancy before 11 weeks of pregnancy | 4 to 11 weeks |
| Ongoing pregnancy | Successgful pregnancy beyond 8 weeks of gestation with a heart beat | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Live birth rate | Viable successful delivery of a life baby | 40 weeks |
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Inclusion Criteria:
Exclusion Criteria:
Pregnancy required
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| ID | Term |
|---|---|
| D011374 | Progesterone |
| ID | Term |
|---|---|
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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RCT
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| hCG | Drug | Given by subcutaneous injection |
|
|
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D003339 | Corpus Luteum Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D045167 | Progesterone Congeners |
| D012739 | Gonadal Steroid Hormones |