Recurrent Pregnancy Loss Without Current PregnancyPhase 2HOPENCT05365464
HOPE Trial hCG or Progesterone Effect on Recurrent Pregnancy Loss
A Phase 2 study testing Progesterone Pill and hCG in people with Recurrent Pregnancy Loss Without Current Pregnancy, run by Wake Forest University Health Sciences.
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. Read more about this study
- Who is it for?
- Ages 18 to 42 years, women only
- Conditions the study is for
- Recurrent Pregnancy Loss Without Current Pregnancy
- What is being tested?
- Progesterone Pill and hCG
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- May 2022to Dec 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 42 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 2 first trimester losses
- unexplained recurrent pregnancy loss
Who cannot join
- Antiphospholipid syndrome
- uterine septum
- Asherman's syndrome
- Paternal or maternal genetic abnormalities (i.e. balanced translocation)
- Endocrine causes of RPL (thyroid, diabetes, hyperprolactinemia)
About this study
Official title: hCG or Progesterone Effect on Unexplained Recurrent Pregnancy Loss
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.
Read the detailed 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.
- Being tested
- Progesterone Pill, hCG
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Progesterone PillDrug
Also called Prometrium
Orally active progesterone
hCGDrug
Also called Ovidril
Given by subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| Progesterone | Active comparator | Women receive prometrium 200 mg qhs for up to 8 weeks Receives: 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 Receives: Drug: hCG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Miscarriage
Loss of pregnancy before 11 weeks of pregnancy
Measured: 4 to 11 weeks
Ongoing pregnancy
Successgful pregnancy beyond 8 weeks of gestation with a heart beat
Measured: 8 weeks
Secondary outcomes (1)
Live birth rate
Viable successful delivery of a life baby
Measured: 40 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2022
- Study startMay 2022 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Why it stopped: Investigator still working on protocol and not sure when it will be ready
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Pregnancy Loss Without Current PregnancyStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- RCT
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05365464
- Sponsor's protocol ID
- BL3HOPE
- Acronym
- HOPE
- Status last verified
- Aug 2021
- First submitted
- 4 May 2022
- Last updated
- 9 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- hCG or Progesterone Effect on Unexplained Recurrent Pregnancy Loss
- ClinicalTrials.gov ID
- NCT05365464
- Acronym / sponsor ID
- HOPE / BL3HOPE
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Investigator still working on protocol and not sure when it will be ready
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- May 2022 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 9 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- RCT
| Arm | Type | Receives |
|---|---|---|
| Progesterone | Active comparator | Drug: Progesterone PillWomen receive prometrium 200 mg qhs for up to 8 weeks |
| hCG | Active comparator | Drug: hCGA single shot of hCG (ovidril 250 ug) will be given as a subcutaneous injection 1 week after ovulation |
Who may qualify
- Ages
- 18 to 42 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 2 first trimester losses
- unexplained recurrent pregnancy loss
Key exclusion criteria (5 listed)
- Antiphospholipid syndrome
- uterine septum
- Asherman's syndrome
- Paternal or maternal genetic abnormalities (i.e. balanced translocation)
- Endocrine causes of RPL (thyroid, diabetes, hyperprolactinemia)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Progesterone PillAlso: PrometriumOrally active progesterone | Drug | Progesterone |
| hCGAlso: OvidrilGiven by subcutaneous injection | Drug | hCG |
Primary outcome
Miscarriage
Time frame: 4 to 11 weeks
Loss of pregnancy before 11 weeks of pregnancy
Ongoing pregnancy
Time frame: 8 weeks
Successgful pregnancy beyond 8 weeks of gestation with a heart beat
1 secondary outcome
Live birth rate
Time frame: 40 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2022.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Progesterone Pill and hCG in people with Recurrent Pregnancy Loss Without Current Pregnancy, run by Wake Forest University Health Sciences.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 9 May 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Miscarriage (time frame: 4 to 11 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2022.