HOPE Trial hCG or Progesterone Effect on Recurrent Pregnancy Loss

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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hCG or Progesterone Effect on Unexplained Recurrent Pregnancy Loss

Conditions
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Recurrent Pregnancy Loss Without Current Pregnancy

Intervention / Treatment
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* Drug: Progesterone Pill
* Drug: hCG


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 2 first trimester losses unexplained recurrent pregnancy loss Exclusion Criteria: Antiphospholipid syndrome uterine septum Asherman's syndrome Paternal or maternal genetic abnormalities (i.e. balanced translocation) Endocrine causes of RPL (thyroid, diabetes, hyperprolactinemia)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 42 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: RCT
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Progesterone<br>Women receive prometrium 200 mg qhs for up to 8 weeks | Drug: Progesterone Pill<br>* Orally active progesterone<br>* Other names: Prometrium;|
| Active Comparator: hCG<br>A single shot of hCG (ovidril 250 ug) will be given as a subcutaneous injection 1 week after ovulation | Drug: hCG<br>* Given by subcutaneous injection<br>* Other names: Ovidril;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Live birth rate | Viable successful delivery of a life baby | 40 weeks |