PC Protocol: Preconceptional Screening (PC)
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|ClinicalTrials.gov Identifier: NCT02309073|
Recruitment Status : Recruiting
First Posted : December 5, 2014
Last Update Posted : December 12, 2018
Background: Despite considerable progress in the field of assisted reproductive technology (ART) maximum pregnancy rates generally do not exceed 30%. Furthermore, substantial differences in pregnancy rates are seen between women starting ART from seemingly similar clinical starting points and information on pregnancy/neonatal complications after ART is limited. For physicians and patients it would be extremely valuable if tools could be developed through which individualised chances of live birth and the development of pregnancy/neonatal complications can be calculated. In addition, there is increasing knowledge about health risks associated with subfertility and in particular with polycystic ovarian syndrome (PCOS) and premature ovarian failure (POF). An important void in research to date is the absence of a control group to check important new findings.
Objectives: The study protocol aims to form a cohort of normo-ovulatory women with a regular indication for ART which can aid the investigators principle lines of research:
- To study initial predictors of ovarian response to stimulation for IVF
- To study predictors of chances for live birth after repeated IVF cycles
- To assess the role for vascular health in the probabilities of success in ART treatment
- To study predictors for pregnancy and neonatal complications
- To form a control group for cycle disturbance studies
Study design: In this part of the protocol, serum and material for DNA analysis will be collected by asking patients to have 20 ml of blood drawn during a routine blood withdrawal. This blood will be stored in the Biobank of the UMC Utrecht at -80 C.
Study population: All women starting ART will be asked to participate. Women starting donorinsemination treatment will be asked to participate, from the viewpoint that they potentially will form a normal fertile control group.
Nature and extent of the burden and benefits associated with participation: There are no benefits or risks for the study patient as blood is withdrawn during a routine venapuncture and results will not be used for clinical practice.
|Condition or disease|
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||1500 participants|
|Target Follow-Up Duration:||3 Years|
|Official Title:||PC Protocol: Preconceptional Screening Part 2|
|Study Start Date :||November 2013|
|Estimated Primary Completion Date :||January 2020|
|Estimated Study Completion Date :||January 2021|
women with a regular indication for ART
In the present proposal we are aiming to include all normo-ovulatory women with a regular indication for ART.
women undergoing donor insemination treatment
potential normal fertile control group
- Ovarian response [ Time Frame: 3 years ]number of oocytes, number of cycle cancellations, poor response, hyper response
- Prediction of pregnancy [ Time Frame: 3 years ]prediction of clinical and ongoing pregnancy and live birth
- Number of patients with adverse pregnancy outcome including pregnancy induced hypertension,pre-eclampsia, HELLP syndrome, diabetes, premature birth, intrauterine growth restriction [ Time Frame: 3 years ]
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02309073
|Contact: Bart Fauser, MD PhDfirstname.lastname@example.org|
|Contact: Frank Broekmans, MD PhDemail@example.com|
|Utrecht, Netherlands, 3508 GA|
|Contact: Bart Fauser, MD PhD firstname.lastname@example.org|
|Principal Investigator: Bart Fauser, MD PhD|
|Sub-Investigator: Frank Broekmans, MD PhD|
|Sub-Investigator: Helen Torrance, MD PhD|
|Principal Investigator:||Bart Fauser, MD PhD||UMC Utrecht|