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PC Protocol: Preconceptional Screening (PC)

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ClinicalTrials.gov Identifier: NCT02309073
Recruitment Status : Recruiting
First Posted : December 5, 2014
Last Update Posted : May 16, 2017
Sponsor:
Information provided by (Responsible Party):
Bart CJM Fauser, 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.

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burden and benefits associated with participation: There are no benefits or risks for the study patient as blood is withdrawn during a routine venapuncture and results will not be used for clinical practice.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

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 [Patient Registry]
Estimated Enrollment : 1500 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
Official Title: PC Protocol: Preconceptional Screening Part 2
Study Start Date : November 2013
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : January 2020

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.



Primary Outcome Measures :
  1. Ovarian response [ Time Frame: 3 years ]
    number of oocytes, number of cycle cancellations, poor response, hyper response


Secondary Outcome Measures :
  1. Prediction of pregnancy [ Time Frame: 3 years ]
    prediction of clinical and ongoing pregnancy and live birth

  2. 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
Blood will be drawn for later determination of various parameters. DNA will also be extracted.


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

  • normo-ovulatory with a regular indication for ART

Exclusion Criteria:

  • Women with cycle disturbances

Information from the National Library of Medicine

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


Contacts
Contact: Bart Fauser, MD PhD b.fauser@umcutrecht.nl
Contact: Frank Broekmans, MD PhD f.broekmans@umcutrecht.nl

Locations
Netherlands
UMC Utrecht Recruiting
Utrecht, Netherlands, 3508 GA
Contact: Bart Fauser, MD PhD       b.fauser@umcutrecht.nl   
Principal Investigator: Bart Fauser, MD PhD         
Sub-Investigator: Frank Broekmans, MD PhD         
Sub-Investigator: Helen Torrance, MD PhD         
Sponsors and Collaborators
UMC Utrecht
Investigators
Principal Investigator: Bart Fauser, MD PhD UMC Utrecht