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HOPE Trial hCG or Progesterone Effect on Recurrent Pregnancy Loss

NCT05365464 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2022-05-09

No results posted yet for this study

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.

Conditions

  • Recurrent Pregnancy Loss Without Current Pregnancy

Interventions

DRUG

Progesterone Pill

Orally active progesterone

DRUG

hCG

Given by subcutaneous injection

Sponsors & Collaborators

  • Wake Forest University Health Sciences

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
42 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-31
Primary Completion
2025-12-31
Completion
2025-12-31
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05365464 on ClinicalTrials.gov