WithdrawnPhase 2

HOPE Trial hCG or Progesterone Effect on Recurrent Pregnancy Loss

Stopped: Investigator still working on protocol and not sure when it will be ready

0Started 2022-05

Plain-language 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.

Who can participate

Age range

18 Years – 42 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Miscarriage

Timeframe: 4 to 11 weeks

Ongoing pregnancy

Timeframe: 8 weeks

Trial details

NCT IDNCT05365464

SponsorWake Forest University Health Sciences

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12

View on ClinicalTrials.gov More Recurrent Pregnancy Loss Without Current Pregnancy trials