NCT05365464

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started May 2022

Typical duration for phase_2

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2022

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

May 4, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 9, 2022

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

May 9, 2022

Status Verified

August 1, 2021

Enrollment Period

3.6 years

First QC Date

May 4, 2022

Last Update Submit

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
  • 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.

Sponsors & Collaborators

MeSH Terms

Interventions

Progesterone

Intervention Hierarchy (Ancestors)

PregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsCorpus Luteum HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsProgesterone CongenersGonadal Steroid Hormones
0

Study Design

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

Study Record Dates

First Submitted

May 4, 2022

First Posted

May 9, 2022

Study Start

May 1, 2022

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

May 9, 2022

Record last verified: 2021-08