HOPE Trial hCG or Progesterone Effect on Recurrent Pregnancy Loss

Wake Forest University (WFU)

Status and phase: Withdrawn; Phase 2

Conditions: Recurrent Pregnancy Loss Without Current Pregnancy

Treatments: Drug: hCG; Drug: Progesterone Pill

Study type: Interventional

Funder types: Other

Identifiers

NCT05365464

BL3HOPE

Details and patient eligibility

About

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.

Full description

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.

Sex: Female

Ages: 18 to 42 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Progesterone

Active Comparator group

Description:

Women receive prometrium 200 mg qhs for up to 8 weeks

Treatment:

Drug: Progesterone Pill

hCG

Active Comparator group

Description:

A single shot of hCG (ovidril 250 ug) will be given as a subcutaneous injection 1 week after ovulation

Treatment:

Drug: hCG