HOPE Trial hCG or Progesterone Effect on Recurrent Pregnancy Loss

NCT ID: NCT05365464

Last Updated: 2022-05-09

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-31
• Study Completion Date: 2025-12-31

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.

Conditions

Recurrent Pregnancy Loss Without Current Pregnancy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Progesterone

Women receive prometrium 200 mg qhs for up to 8 weeks

Group Type: ACTIVE_COMPARATOR

Progesterone Pill

Intervention Type: DRUG

Orally active progesterone

hCG

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

Group Type: ACTIVE_COMPARATOR

hCG

Intervention Type: DRUG

Given by subcutaneous injection

Interventions

Progesterone Pill

Orally active progesterone

Intervention Type: DRUG

hCG

Given by subcutaneous injection

Intervention Type: DRUG

Other Intervention Names

Prometrium; Ovidril

Eligibility 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 42 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

BL3HOPE

Identifier Type: -

Identifier Source: org_study_id