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 range18 Years – 42 Years

SexFEMALE

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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)

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