PC Protocol: Preconceptional Screening

Infertility Clinical Trial

— PC  

Official title:

PC Protocol: Preconceptional Screening Part 2

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02309073
• Other study ID #: 13-109
• Status: Recruiting
• Start date: November 2013
• Est. completion date: January 2023

Study information

• Verified date: October 2021
• Source: UMC Utrecht
• Contact: Bart Fauser, MD PhD
• Email: b.fauser[@]umcutrecht.nl
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1500
• Est. completion date: January 2023
• Est. primary completion date: January 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Women with cycle disturbances

Related Conditions & MeSH terms

• Infertility

Locations

Country	Name	City	State
Netherlands	UMC Utrecht	Utrecht

Sponsors (1)

Lead Sponsor	Collaborator
UMC Utrecht

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ovarian response	number of oocytes, number of cycle cancellations, poor response, hyper response	3 years
Secondary	Prediction of pregnancy	prediction of clinical and ongoing pregnancy and live birth	3 years
Secondary	Adverse pregnancy outcome	Number of patients with adverse pregnancy outcome including pregnancy induced hypertension,pre-eclampsia, HELLP syndrome, diabetes, premature birth, intrauterine growth restriction	3 years