HOPE Trial hCG or Progesterone Effect on Recurrent Pregnancy Loss

• Status: Withdrawn
• Trial end date: 2025-12-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Wake Forest University Health Sciences
• Treatments: Progesterone

Criteria

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)