HOPE Trial hCG or Progesterone Effect on Recurrent Pregnancy Loss (HOPE)

May 4, 2022 updated by: Wake Forest University Health Sciences

hCG or Progesterone Effect on Unexplained Recurrent Pregnancy Loss

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 42 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Progesterone
Women receive prometrium 200 mg qhs for up to 8 weeks
Drug: Progesterone Pill
Orally active progesterone
Other Names:
  • Prometrium
ACTIVE_COMPARATOR: hCG
A single shot of hCG (ovidril 250 ug) will be given as a subcutaneous injection 1 week after ovulation
Drug: hCG
Given by subcutaneous injection
Other Names:
  • Ovidril

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Miscarriage
Time Frame: 4 to 11 weeks
Loss of pregnancy before 11 weeks of pregnancy
4 to 11 weeks
Ongoing pregnancy
Time Frame: 8 weeks
Successgful pregnancy beyond 8 weeks of gestation with a heart beat
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Live birth rate
Time Frame: 40 weeks
Viable successful delivery of a life baby
40 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wake Forest University Health Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

May 1, 2022

Primary Completion (ANTICIPATED)

December 1, 2025

Study Completion (ANTICIPATED)

December 1, 2025

Study Registration Dates

First Submitted

May 4, 2022

First Submitted That Met QC Criteria

May 4, 2022

First Posted (ACTUAL)

May 9, 2022

Study Record Updates

Last Update Posted (ACTUAL)

May 9, 2022

Last Update Submitted That Met QC Criteria

May 4, 2022

Last Verified

August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BL3HOPE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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