Recurrent Pregnancy LossOPALNCT05167812
On Pregnancy After Losses - OPAL Study
An observational study of Recurrent Pregnancy Loss, run by Leiden University Medical Center.
Trial summary
Rationale: Recurrent pregnancy loss (RPL) is defined as the loss of two or more conceptions before the fetus reaches viability. It affects 1-3% of all fertile couples and despite extensive diagnostic work-up, in only around 30% an underlying cause is identified. Read more about this study
- Who is it for?
- Ages 18 to 42 years
- Conditions the study is for
- Recurrent Pregnancy Loss
- What is being tested?
- Observation of pregnancies after intake
- How many people
- 1,931 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2022to 1 Feb 2028
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- All sexes
- No healthy volunteers
- Adult
Study population: Couples with RPL who have visited or will visit an "early pregnancy unit" or "RPL outpatient clinic" of the Leiden University Medical Centre (LUMC), Erasmus Medical Centre (EMC) or Amsterdam University Medical Centre (Amsterdam UMC) from 2006 onwards.
Who may be able to join
- Couples that fulfill the following criteria are included (according to the ESHRE Recurrent Pregnancy Loss Guideline 2017):
- RPL in the current relationship: defined as the loss of ≥ 2 preceding pregnancies. These pregnancy losses include:
- all pregnancy losses before the 24th week of gestation verified by ultrasonography or uterine curettage and histology
- non-visualized pregnancies (including biochemical pregnancy losses and/or resolved and treated pregnancies of unknown location), verified by positive urine or serum hCG
- both consecutive and non-consecutive pregnancy losses
- Dutch or English speaking couple
- Couples with females aged ≤42 years at intake
Who cannot join
- Mental or legal incapability of either the male or female of the couple
- Loss of < 2 pregnancies in current relationship
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: On Pregnancy After Losses; Predicting Pregnancy Success in Couples With Recurrent Pregnancy Loss
Rationale:
Recurrent pregnancy loss (RPL) is defined as the loss of two or more conceptions before the fetus reaches viability. It affects 1-3% of all fertile couples and despite extensive diagnostic work-up, in only around 30% an underlying cause is identified. Several factors may increase the risk for miscarriage, but the chance of a normal, successful pregnancy is still high. So, in supporting couples with RPL, an important part of the clinical management of these couples is to provide couples with accurate prognoses for their next pregnancy. The main limitation in current prediction models is the lack of a sufficiently large cohort, adjustment for relevant risk factors such that prognoses are individualized, and separating between the cumulative live birth rate and the chance that the next conception will lead to a live birth. In this project therefore we aim to make an individualized prognosis regarding the future chance of live birth and the chance of a healthy child. This could then lead to improved wellbeing and the ability of making future reproductive choices.
Read more
Objectives:
Primary objective: to predict the chance of a live birth within three years after intake in couples with unexplained RPL
Secondary objectives:
- to predict the chance of an ongoing pregnancy (>12 weeks) in the next pregnancy in couples with unexplained RPL.
- to predict the chance of a complicated pregnancy in couples with unexplained RPL
- to predict the chance dynamically of a live birth given the outcome of a pregnancy after intake
- to predict the chance of above outcomes in couples with a known cause for RPL
Study design: A multicenter retrospective and prospective cohort study.
Study population:
Couples with females aged ≤42 years in both prospective and retrospective inclusion.
Retrospective inclusion: Couples with RPL who visited the RPL outpatient clinic in participating centers from 2006 until the start of this study.
Prospective inclusion: new couples with RPL who will visit the clinic from 2021 onwards.
Main study parameters/endpoints:
- Pregnancy outcomes since intake
- Time to pregnancy since intake
- Time between pregnancies since intake
- Pregnancy complications since intake
- All outcomes will be obtained up to a maximum of five years after intake
- Patient characteristics: cause for RPL, female age, male age, previous live birth, duration of RPL (since diagnosis)
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
Participating in this study does not yield any risks. There could be a burden in case of retrospectively collecting data. Participating does not yield direct benefits for the subjects, however it may lead to future improvements of care for couples with RPL.
- Conditions
- Recurrent Pregnancy Loss
- Being tested
- Observation of pregnancies after intake
- Keywords
- Prediction, Prognosis, Live birth, Pregnancy success chance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observation of pregnancies after intakeOther
Monitoring pregnancies after intake at a dedicated recurrent pregnancy loss clinic to predict pregnancy success chances in couples with recurrent pregnancy loss
| Study group | Role | What they receive |
|---|---|---|
| Prospective cohort of couples with RPL | Not described Receives: Other: Observation of pregnancies after intake | |
| Retrospective cohort op couples with RPL | Not described Receives: Other: Observation of pregnancies after intake |
What is being measured
The primary outcome is the main question the study is designed to answer.
Live birth of RPL couples within three years assessed by ultrasound or hCG after intake at the RPL clinic
Measured: 3 - 5 years
Secondary outcomes (4)
Pregnancy outcomes since intake (miscarriage, ongoing pregnancy, live birth) assessed by ultrasound, hCG, or "take home baby"
miscarriages are assessed via ultrasound or pregnancy tests (positive test later followed by negative test). Ongoing pregnancy when ultrasound assessment is known but further follow up is missing, and live birth when pregnancy ends with the live birth of a child.
Measured: 3 - 5 years
Time to pregnancy since intake measured in days
Time that has passed since couple had an intake at the RPL clinic until first pregnancy, measured in days until the first day of the last menstruation of the first pregnancy after intake
Measured: 3 - 5 years
Time between pregnancies since intake measured in days
Time that has passed between each pregnancy a couple had since intake at the RPL clinic, measured in days between the end of the last pregnancy and until the first day of the last menstruation of the new pregnancy
Measured: 3 - 5 years
Pregnancy complications since intake as registered by gynecologist or midwife
All complications during pregnancy and during labor registered by caregiver (gynecologist or midwife) in all pregnancies after intake at the RPL clinic
Measured: 3 - 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2021
- Study start1 Feb 2022 (estimated)
- Primary completion1 Feb 2026 (estimated)
- Study completion1 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Recurrent Pregnancy LossStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,931 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Leiden University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ayoussef, Leiden University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05167812
- Sponsor's protocol ID
- P_2022
- Acronym
- OPAL
- Status last verified
- Dec 2021
- First submitted
- 7 Dec 2021
- Last updated
- 22 Dec 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Youssef A, van der Hoorn ML, van Eekelen R, van Geloven N, van Wely M, Smits MAJ, Mulders A, van Lith JM, Goddijn M, Lashley E. Development of the OPAL prediction model for prediction of live birth in couples with recurrent pregnancy loss: protocol for a prospective and retrospective cohort study in the Netherlands. BMJ Open. 2022 Sep 23;12(9):e062402. doi: 10.1136/bmjopen-2022-062402.
PubMed 36153018
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- On Pregnancy After Losses; Predicting Pregnancy Success in Couples With Recurrent Pregnancy Loss
- ClinicalTrials.gov ID
- NCT05167812
- Acronym / sponsor ID
- OPAL / P_2022
- Conditions
- Recurrent Pregnancy Loss
- Keywords
- Prediction, Prognosis, Live birth, Pregnancy success chance
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,931 participants (estimated)
- Lead sponsor
- Leiden University Medical CenterUniversity, hospital or other
- Study start
- 1 Feb 2022 (estimated)
- Primary completion
- 1 Feb 2026 (estimated)
- Study completion
- 1 Feb 2028 (estimated)
- First posted
- 22 Dec 2021 (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.
Rationale:
Recurrent pregnancy loss (RPL) is defined as the loss of two or more conceptions before the fetus reaches viability. It affects 1-3% of all fertile couples and despite extensive diagnostic work-up, in only around 30% an underlying cause is identified. Several factors may increase the risk for miscarriage, but the chance of a normal, successful pregnancy is still high. So, in supporting couples with RPL, an important part of the clinical management of these couples is to provide couples with accurate prognoses for their next pregnancy. The main limitation in current prediction models is the lack of a sufficiently large cohort, adjustment for relevant risk factors such that prognoses are individualized, and separating between the cumulative live birth rate and the chance that the next conception will lead to a live birth. In this project therefore we aim to make an individualized prognosis regarding the future chance of live birth and the chance of a healthy child. This could then lead to improved wellbeing and the ability of making future reproductive choices.
Objectives:
Primary objective: to predict the chance of a live birth within three years after intake in couples with unexplained RPL
Secondary objectives:
- to predict the chance of an ongoing pregnancy (>12 weeks) in the next pregnancy in couples with unexplained RPL.
- to predict the chance of a complicated pregnancy in couples with unexplained RPL
- to predict the chance dynamically of a live birth given the outcome of a pregnancy after intake
- to predict the chance of above outcomes in couples with a known cause for RPL
Study design: A multicenter retrospective and prospective cohort study.
Study population:
Couples with females aged ≤42 years in both prospective and retrospective inclusion.
Retrospective inclusion: Couples with RPL who visited the RPL outpatient clinic in participating centers from 2006 until the start of this study.
Prospective inclusion: new couples with RPL who will visit the clinic from 2021 onwards.
Main study parameters/endpoints:
- Pregnancy outcomes since intake
- Time to pregnancy since intake
- Time between pregnancies since intake
- Pregnancy complications since intake
- All outcomes will be obtained up to a maximum of five years after intake
- Patient characteristics: cause for RPL, female age, male age, previous live birth, duration of RPL (since diagnosis)
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
Participating in this study does not yield any risks. There could be a burden in case of retrospectively collecting data. Participating does not yield direct benefits for the subjects, however it may lead to future improvements of care for couples with RPL.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prospective cohort of couples with RPL | – | Other: Observation of pregnancies after intake |
| Retrospective cohort op couples with RPL | – | Other: Observation of pregnancies after intake |
Who may qualify
- Ages
- 18 to 42 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Couples with RPL who have visited or will visit an "early pregnancy unit" or "RPL outpatient clinic" of the Leiden University Medical Centre (LUMC), Erasmus Medical Centre (EMC) or Amsterdam University Medical Centre (Amsterdam UMC) from 2006 onwards.
Key inclusion criteria (7 listed)
- Couples that fulfill the following criteria are included (according to the ESHRE Recurrent Pregnancy Loss Guideline 2017):
- RPL in the current relationship: defined as the loss of ≥ 2 preceding pregnancies. These pregnancy losses include:
- Dutch or English speaking couple
- Couples with females aged ≤42 years at intake
Key exclusion criteria (2 listed)
- Mental or legal incapability of either the male or female of the couple
- Loss of < 2 pregnancies in current relationship
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 |
|---|---|---|
| Observation of pregnancies after intakeMonitoring pregnancies after intake at a dedicated recurrent pregnancy loss clinic to predict pregnancy success chances in couples with recurrent pregnancy loss | Other | Prospective cohort of couples with RPL, Retrospective cohort op couples with RPL |
Primary outcome
Live birth of RPL couples within three years assessed by ultrasound or hCG after intake at the RPL clinic
Time frame: 3 - 5 years
4 secondary outcomes
Pregnancy outcomes since intake (miscarriage, ongoing pregnancy, live birth) assessed by ultrasound, hCG, or "take home baby"
Time frame: 3 - 5 years
Time to pregnancy since intake measured in days
Time frame: 3 - 5 years
Time between pregnancies since intake measured in days
Time frame: 3 - 5 years
Pregnancy complications since intake as registered by gynecologist or midwife
Time frame: 3 - 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2021.
- Derived from this study: PubMed 36153018Youssef A, van der Hoorn ML, van Eekelen R, van Geloven N, van Wely M, Smits MAJ, Mulders A, van Lith JM, Goddijn M, Lashley E. Development of the OPAL prediction model for prediction of live birth in couples with recurrent pregnancy loss: protocol for a prospective and retrospective cohort study in the Netherlands. BMJ Open. 2022 Sep 23;12(9):e062402. doi: 10.1136/bmjopen-2022-062402.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Recurrent Pregnancy Loss, run by Leiden University Medical Center.
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 7 inclusion and 2 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: opening soon, as of the sponsor's last update on 22 Dec 2021. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Angelos Youssef, MD (+31715262896, a.youssef@lumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Live birth of RPL couples within three years assessed by ultrasound or hCG after intake at the RPL clinic (time frame: 3 - 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05167812, which also lists 1 linked publication.
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 22 Dec 2021.