NCT05365464

WithdrawnPhase 2

HOPE Trial hCG or Progesterone Effect on Recurrent Pregnancy...

Wake Forest University Health Sciences Source

Wake Forest University Health Sciences ClinicalTrials.gov

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Other study identifiers

Sponsor study identifier

BL3HOPE

Study Type

interventional

Actual enrollment (reported)

0

Locations

0 countries

Sites

N/A

Timeline

Study Start

May 2022

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Primary Completion

December 2025

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Study Completion

December 2025

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: withdrawn
Actual enrollment (reported): 0 participants
Study completion date: December 2025
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Listed locations: 0 countries · 0 sites

Trial Relationships

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Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
May 2022
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
First Submitted
May 4, 2022
Actual (reported)
First Posted
May 9, 2022
Actual (reported)
Primary Completion
December 2025
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2025
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.

Last Updated: May 9, 2022
Status Verified: August 2021
Last Update Submitted: May 4, 2022

Conditions

Recurrent Pregnancy Loss Without Current Pregnancy

Outcome Measures

Primary Outcomes (2)

Miscarriage
Loss of pregnancy before 11 weeks of pregnancy
4 to 11 weeks
Ongoing pregnancy
Successgful pregnancy beyond 8 weeks of gestation with a heart beat
8 weeks

Secondary Outcomes (1)

Live birth rate
40 weeks

Study Arms (2)

Progesterone

ACTIVE COMPARATOR

Women receive prometrium 200 mg qhs for up to 8 weeks

Drug: Progesterone Pill

hCG

ACTIVE COMPARATOR

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

Drug: hCG

Interventions

Progesterone PillDrug

Orally active progesterone

Also known as: Prometrium

Progesterone

hCGDrug

Given by subcutaneous injection

Also known as: Ovidril

hCG

Eligibility Criteria

Age18 Years - 42 Years

Sexfemale(Gender-based eligibility)

Gender Eligibility DetailsPregnancy required

Healthy VolunteersNo

Age GroupsAdult (18-64)

You may qualify if:

first trimester losses

Sponsors & Collaborators

Wake Forest University Health Sciences
Otherlead

MeSH Terms

Interventions

Progesterone

Intervention Hierarchy (Ancestors)

PregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsCorpus Luteum HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsProgesterone CongenersGonadal Steroid Hormones

Enrollment

0 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 2
Allocation: RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

May 4, 2022

First Posted

May 9, 2022

Study Start

May 2022

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

NCT01972464

Progesterone for Smoking Relapse Prevention Following Delivery

Phase 2Completed

NCT02145767

Progesterone for the Prevention of Miscarriage and Preterm Birth in Women With First Trimester Bleeding: PREEMPT Trial

Phase 2Completed

NCT03633175

Progesterone in Patients With Placenta Previa

Phase 2Unknown

NCT02400021

Progesterone Supplementation for HIV-positive Pregnant Women on Anti-Retrovirals

Phase 2Unknown

NCT02841137

Efficacy Study of Progesterone Tablet in Post-menopausal Women

Phase 2Completed

NCT02846909

The Vaginal Progesterone and Cerclage

Phase 2Completed

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

unexplained recurrent pregnancy loss

You may not qualify if:

Antiphospholipid syndrome
uterine septum
Asherman's syndrome
Paternal or maternal genetic abnormalities (i.e. balanced translocation)
Endocrine causes of RPL (thyroid, diabetes, hyperprolactinemia)

Contact the study team to confirm eligibility.

Primary Completion

December 2025

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Study Completion

December 2025

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Last Updated

May 9, 2022

Record last verified: 2021-08

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT05365464
Data provider: ClinicalTrials.gov
Source updated: 2022-05-09
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:35:59 UTC

Study Stopped

HOPE Trial hCG or Progesterone Effect on Recurrent Pregnancy Loss

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (1)

Study Arms (2)

Progesterone

hCG

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (1)

Study Arms (2)

Progesterone

hCG

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record