PC Protocol: Preconceptional Screening (PC)

October 12, 2021 updated by: Bart CJM Fauser, UMC Utrecht

PC Protocol: Preconceptional Screening Part 2

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burden and benefits associated with participation: There are no benefits or risks for the study patient as blood is withdrawn during a routine venapuncture and results will not be used for clinical practice.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Anticipated)

1500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Netherlands
      • Utrecht, Netherlands, 3508 GA
        • Recruiting
        • UMC Utrecht
        • Contact:
        • Principal Investigator:
          • Bart Fauser, MD PhD
        • Sub-Investigator:
          • Frank Broekmans, MD PhD
        • Sub-Investigator:
          • Helen Torrance, MD PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

In the present proposal we are aiming to include all normo-ovulatory women with a regular indication for ART or undergoing donorinsemination

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Women with cycle disturbances

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ovarian response
Time Frame: 3 years
number of oocytes, number of cycle cancellations, poor response, hyper response
3 years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UMC Utrecht

Investigators

  • Principal Investigator: Bart Fauser, MD PhD, UMC Utrecht

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (Anticipated)

January 1, 2022

Study Completion (Anticipated)

January 1, 2023

Study Registration Dates

First Submitted

November 6, 2013

First Submitted That Met QC Criteria

December 2, 2014

First Posted (Estimate)

December 5, 2014

Study Record Updates

Last Update Posted (Actual)

October 20, 2021

Last Update Submitted That Met QC Criteria

October 12, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13-109

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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