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HOPE Trial hCG or Progesterone Effect on Recurrent Pregnancy Loss

Sponsor
Wake Forest University Health Sciences (Other)
Overall Status
Withdrawn
CT.gov ID
NCT05365464
Collaborator
(none)
0
Enrollment
2
Arms
43
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

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 Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
RCTRCT
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
hCG or Progesterone Effect on Unexplained Recurrent Pregnancy Loss
Anticipated Study Start Date :
May 1, 2022
Anticipated Primary Completion Date :
Dec 1, 2025
Anticipated Study Completion Date :
Dec 1, 2025

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Miscarriage [4 to 11 weeks]

      Loss of pregnancy before 11 weeks of pregnancy

    2. Ongoing pregnancy [8 weeks]

      Successgful pregnancy beyond 8 weeks of gestation with a heart beat

    Secondary Outcome Measures

    1. Live birth rate [40 weeks]

      Viable successful delivery of a life baby

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 42 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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)

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Wake Forest University Health Sciences

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Wake Forest University Health Sciences
    ClinicalTrials.gov Identifier:
    NCT05365464
    Other Study ID Numbers:
    • BL3HOPE
    First Posted:
    May 9, 2022
    Last Update Posted:
    May 9, 2022
    Last Verified:
    Aug 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    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
    Additional relevant MeSH terms:
    Abortion, Spontaneous
    Fetal Death
    Abortion, Habitual
    Recurrence
    Progesterone

    Study Results

    No Results Posted as of May 9, 2022