NCT02309073

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. 1.To study initial predictors of ovarian response to stimulation for IVF
  2. 2.To study predictors of chances for live birth after repeated IVF cycles
  3. 3.To assess the role for vascular health in the probabilities of success in ART treatment
  4. 4.To study predictors for pregnancy and neonatal complications
  5. 5.To form a control group for cycle disturbance studies

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2013

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

November 6, 2013

Completed
1.1 years until next milestone

First Posted

Study publicly available on registry

December 5, 2014

Completed
7.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
Last Updated

October 20, 2021

Status Verified

October 1, 2021

Enrollment Period

8.2 years

First QC Date

November 6, 2013

Last Update Submit

October 12, 2021

Conditions

Infertility

Outcome Measures

Primary Outcomes (1)

  • Ovarian response

    number of oocytes, number of cycle cancellations, poor response, hyper response

    3 years

Secondary Outcomes (2)

  • Prediction of pregnancy

    3 years

  • Adverse pregnancy outcome

    3 years

Study Arms (2)

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

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability 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

You may qualify if:

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

You may not qualify if:

  • Women with cycle disturbances

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UMC Utrecht

Utrecht, 3508 GA, Netherlands

RECRUITING

Related Publications (2)

  • Hamdine O, Eijkemans MJC, Lentjes EGW, Torrance HL, Macklon NS, Fauser BCJM, Broekmans FJ. Antimullerian hormone: prediction of cumulative live birth in gonadotropin-releasing hormone antagonist treatment for in vitro fertilization. Fertil Steril. 2015 Oct;104(4):891-898.e2. doi: 10.1016/j.fertnstert.2015.06.030. Epub 2015 Jul 18.

    PMID: 26196233DERIVED

  • Hamdine O, Eijkemans MJ, Lentjes EW, Torrance HL, Macklon NS, Fauser BC, Broekmans FJ. Ovarian response prediction in GnRH antagonist treatment for IVF using anti-Mullerian hormone. Hum Reprod. 2015 Jan;30(1):170-8. doi: 10.1093/humrep/deu266. Epub 2014 Oct 29.

    PMID: 25355590DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

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

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Bart Fauser, MD PhD

    UMC Utrecht

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Bart Fauser, MD PhD

CONTACT

b.fauser@umcutrecht.nl

Frank Broekmans, MD PhD

CONTACT

f.broekmans@umcutrecht.nl

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 6, 2013

First Posted

December 5, 2014

Study Start

November 1, 2013

Primary Completion

January 1, 2022

Study Completion

January 1, 2023

Last Updated

October 20, 2021

Record last verified: 2021-10

Locations

NL(1)