PregnancyPREROVENCT03668184
What Are the Predictive Factors for Preeclampsia in Oocyte Recipients? - PREROVE
An observational study of Pregnancy and Oocyte Donation, run by Rennes University Hospital at 2 sites in France.
Trial summary
The main goal is to determine which risk factors develop preeclampsia in this specific group of oocyte recipients. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pregnancy, Oocyte Donation
- What is being tested?
- preeclampsia
- How many people
- 150 participants
- Where
- 2 sitesFrance
- Study dates
- 2 Jan 2018to 27 Apr 2018
- Phase
- Observational
- 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 years and older
- Women only
- Adult, Older adult
Study population: Patients with a pregnancy of more than 22 weeks of amenorrhea resulting from an oocyte donation.
Who may be able to join
- All major patients with a pregnancy of more than 22 weeks of amenorrhea resulting from an oocyte donation in one of the study centers, having given birth between January 2010 and April 2017 and not opposed to participation in the study.
Who cannot join
- all pregnancies resulting from an oocyte donation abroad, persons of legal age subject to legal protection (safeguard of justice, guardianship, tutorship) and persons deprived of their liberty.
Trial locations and contacts
2 sites in 1 country.
About this study
The main goal is to determine which risk factors develop preeclampsia in this specific group of oocyte recipients.
- Conditions
- Pregnancy, Oocyte Donation
- Being tested
- preeclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
preeclampsiaOther
occurrence of pre-eclampsia
What is being measured
The primary outcome is the main question the study is designed to answer.
occurrence of pre-eclampsia
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2018
- Study start2 Jan 2018
- Primary completion27 Apr 2018
- Study completion27 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Solène DUROS, MD, Principal investigator, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03668184
- Sponsor's protocol ID
- 35RC17_3078_PREROVE
- Acronym
- PREROVE
- Status last verified
- Apr 2023
- First submitted
- 6 Sep 2018
- Last updated
- 12 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- What Are the Predictive Factors for Preeclampsia in Oocyte Recipients? - PREROVE
- ClinicalTrials.gov ID
- NCT03668184
- Acronym / sponsor ID
- PREROVE / 35RC17_3078_PREROVE
- Conditions
- Pregnancy, Oocyte Donation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 2 Jan 2018 (actual)
- Primary completion
- 27 Apr 2018 (actual)
- Study completion
- 27 Apr 2018 (actual)
- First posted
- 12 Sep 2018 (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.
The main goal is to determine which risk factors develop preeclampsia in this specific group of oocyte recipients.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Patients with a pregnancy of more than 22 weeks of amenorrhea resulting from an oocyte donation.
Key inclusion criteria (1 listed)
- All major patients with a pregnancy of more than 22 weeks of amenorrhea resulting from an oocyte donation in one of the study centers, having given birth between January 2010 and April 2017 and not opposed to participation in the study.
Key exclusion criteria (1 listed)
- all pregnancies resulting from an oocyte donation abroad, persons of legal age subject to legal protection (safeguard of justice, guardianship, tutorship) and persons deprived of their liberty.
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 |
|---|---|---|
| preeclampsiaoccurrence of pre-eclampsia | Other | – |
Primary outcome
occurrence of pre-eclampsia
Time frame: through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2023.
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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. This study is not recruiting at the moment.
Solène DUROS, MD principal investigator
Rennes University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy and Oocyte Donation, run by Rennes University Hospital at 2 sites in France.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 12 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
occurrence of pre-eclampsia (time frame: through study completion, an average of 1 year). 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 12 Apr 2023.