PC Protocol: Preconceptional Screening

• Conditions: Infertility

• Registration Number: NCT02309073
• Lead Sponsor: UMC Utrecht

Brief Summary

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:

1. To study initial predictors of ovarian response to stimulation for IVF

2. To study predictors of chances for live birth after repeated IVF cycles

3. To assess the role for vascular health in the probabilities of success in ART treatment

4. To study predictors for pregnancy and neonatal complications

5. 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the burden and benefits associated with participation: There are no benefits or risks for the study patient as blood is withdrawn during a routine venapuncture and results will not be used for clinical practice.

Detailed Description

The aim of this protocol is to collect serum and genotype from normo-ovulatory women with a regular indication for IVF/ICSI that can aid further research into the investigators principle lines of research which include improving performance ART treatment , limiting pregnancy complications, and improving offspring health.

Study Timeline

• Study Start: 2013-11
• Study First Submitted: 2013-11-06
• Study First Submitted QC: 2014-12-02
• Study First Posted: 2014-12-05
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-12
• Last Update Posted: 2021-10-20
• Primary Completion: 2022-01
• Study Completion: 2023-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 1500

Inclusion Criteria

• normo-ovulatory with a regular indication for ART or undergoing donorinsemination

Exclusion Criteria

• Women with cycle disturbances

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Ovarian response	3 years	number of oocytes, number of cycle cancellations, poor response, hyper response

Secondary Outcome Measures

Name	Time	Method
Prediction of pregnancy	3 years	prediction of clinical and ongoing pregnancy and live birth
Adverse pregnancy outcome	3 years	Number of patients with adverse pregnancy outcome including pregnancy induced hypertension,pre-eclampsia, HELLP syndrome, diabetes, premature birth, intrauterine growth restriction

Trial Locations

Locations (1)

UMC Utrecht; 🇳🇱 Utrecht, Netherlands