Ignite Creation Date:
2024-05-06 @ 3:29 AM
Last Modification Date:
2024-10-26 @ 11:35 AM
Study NCT ID:
NCT02309073
Status:
UNKNOWN
Last Update Posted:
2021-10-20
First Post:
2013-11-06
Brief Title:
PC Protocol Preconceptional Screening
Sponsor:
UMC Utrecht
Organization:
UMC Utrecht
Study Overview
Official Title:
PC Protocol Preconceptional Screening Part 2
Status:
UNKNOWN
Status Verified Date:
2021-10
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PC
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 pregnancyneonatal 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 pregnancyneonatal 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
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 IVFICSI 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None