Ignite Creation Date:
2025-12-26 @ 10:46 PM
Ignite Modification Date:
2025-12-26 @ 10:46 PM
Study NCT ID:
NCT05167812
Status:
NOT_YET_RECRUITING
Last Update Posted:
2021-12-22
First Post:
2021-12-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
On Pregnancy After Losses - OPAL Study
Sponsor:
Leiden University Medical Center
Organization:
Study Overview
Official Title:
On Pregnancy After Losses; Predicting Pregnancy Success in Couples With Recurrent Pregnancy Loss
Status:
NOT_YET_RECRUITING
Status Verified Date:
2021-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OPAL
Brief 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. 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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: