HOPE Trial hCG or Progesterone Effect on Recurrent Pregnancy Loss

Phase 2

Withdrawn

• Conditions: Recurrent Pregnancy Loss Without Current Pregnancy
• Interventions: Drug: Progesterone Pill; Drug: hCG

• Registration Number: NCT05365464
• Lead Sponsor: Wake Forest University Health Sciences

Brief Summary

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

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.

Study Timeline

• Status Verified: 2021-08
• Study Start: 2022-05
• Study First Submitted: 2022-05-04
• Study First Submitted QC: 2022-05-04
• Last Update Submitted: 2022-05-04
• Study First Posted: 2022-05-09
• Last Update Posted: 2022-05-09
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Progesterone	Progesterone Pill	Women receive prometrium 200 mg qhs for up to 8 weeks
hCG	hCG	A single shot of hCG (ovidril 250 ug) will be given as a subcutaneous injection 1 week after ovulation

Primary Outcome Measures

Name	Time	Method
Miscarriage	4 to 11 weeks	Loss of pregnancy before 11 weeks of pregnancy
Ongoing pregnancy	8 weeks	Successgful pregnancy beyond 8 weeks of gestation with a heart beat

Secondary Outcome Measures

Name	Time	Method
Live birth rate	40 weeks	Viable successful delivery of a life baby