PC Protocol: Preconceptional Screening

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burden and benefits associated with participation: There are no benefits or risks for the study patient as blood is withdrawn during a routine venapuncture and results will not be used for clinical practice.

Detailed Description
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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.

Official Title
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PC Protocol: Preconceptional Screening Part 2

Conditions
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Infertility

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: normo-ovulatory with a regular indication for ART or undergoing donorinsemination Exclusion Criteria: Women with cycle disturbances

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| women with a regular indication for ART<br>In the present proposal we are aiming to include all normo-ovulatory women with a regular indication for ART. | |
| women undergoing donor insemination treatment<br>potential normal fertile control group | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ovarian response | 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 | prediction of clinical and ongoing pregnancy and live birth | 3 years | 
| 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 |