HOPE Trial hCG or Progesterone Effect on Recurrent Pregnancy Loss

Recurrent Pregnancy Loss Without Current Pregnancy Clinical Trial

— HOPE  

Official title:

hCG or Progesterone Effect on Unexplained Recurrent Pregnancy Loss

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05365464
• Other study ID #: BL3HOPE
• Status: Withdrawn
• Phase: Phase 2
• Start date: May 2022
• Est. completion date: December 2025

Study information

• Verified date: August 2021
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 42 Years

Eligibility

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)

Related Conditions & MeSH terms

• Abortion, Habitual
• Abortion, Spontaneous
• Fetal Death
• Recurrent Pregnancy Loss Without Current Pregnancy

Intervention

Drug:
• Progesterone Pill
Orally active progesterone
• hCG
Given by subcutaneous injection

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Miscarriage	Loss of pregnancy before 11 weeks of pregnancy	4 to 11 weeks
Primary	Ongoing pregnancy	Successgful pregnancy beyond 8 weeks of gestation with a heart beat	8 weeks
Secondary	Live birth rate	Viable successful delivery of a life baby	40 weeks