NCT01411644

Brief Summary

This study focuses on the phenotyping and genotyping of women with hypergonadotropic ovarian dysfunction (WHO III status).

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
650

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2005

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

January 1, 2005

Completed
6.6 years until next milestone

First Submitted

Initial submission to the registry

August 5, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 8, 2011

Completed
8.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
Last Updated

December 11, 2018

Status Verified

December 1, 2018

Enrollment Period

15.4 years

First QC Date

August 5, 2011

Last Update Submit

December 10, 2018

Conditions

Premature Ovarian Failure (POF)Incipient Ovarian FailurePoor Response After Ovarian HyperstimulationEarly MenopauseHypergonadotropic Amenorrhea

Keywords

POFIOFPoor responseearly menopausePrimary amenorrhea

Eligibility Criteria

Age12 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Women with WHO III status who attend the outpatient clinic of participating hospitals.

You may qualify if:

  • POF; defined as secondary amenorrhea before 40 years of age and basal FSH \> 40 IU/L
  • Incipient ovarian failure; defined as normo-ovulatory cycles, raised basal FSH \> 12 IU/L
  • Poor response patients; defined as less than 4 oocytes retrieved or cancellation in case of absent follicle growth after ovarian hyperstimulation with 300 IU gonadotropins or cancellation in case of absent follicle growth
  • Women with early menopause (between 40-45 years)
  • Hypergonadotropic primary amenorrhea

You may not qualify if:

  • Primary amenorrhea with early development disorders causing absence of ovaries and Swyer syndrome (XY)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UMC Utrecht

Utrecht, 3508 GA, Netherlands

RECRUITING

Related Publications (5)

  • Knauff EA, Franke L, van Es MA, van den Berg LH, van der Schouw YT, Laven JS, Lambalk CB, Hoek A, Goverde AJ, Christin-Maitre S, Hsueh AJ, Wijmenga C, Fauser BC; Dutch POF Consortium. Genome-wide association study in premature ovarian failure patients suggests ADAMTS19 as a possible candidate gene. Hum Reprod. 2009 Sep;24(9):2372-8. doi: 10.1093/humrep/dep197. Epub 2009 Jun 9.

    PMID: 19508998BACKGROUND

  • Knauff EA, Westerveld HE, Goverde AJ, Eijkemans MJ, Valkenburg O, van Santbrink EJ, Fauser BC, van der Schouw YT. Lipid profile of women with premature ovarian failure. Menopause. 2008 Sep-Oct;15(5):919-23. doi: 10.1097/gme.0b013e31816b4509.

    PMID: 18551082RESULT

  • Knauff EA, Eijkemans MJ, Lambalk CB, ten Kate-Booij MJ, Hoek A, Beerendonk CC, Laven JS, Goverde AJ, Broekmans FJ, Themmen AP, de Jong FH, Fauser BC; Dutch Premature Ovarian Failure Consortium. Anti-Mullerian hormone, inhibin B, and antral follicle count in young women with ovarian failure. J Clin Endocrinol Metab. 2009 Mar;94(3):786-92. doi: 10.1210/jc.2008-1818. Epub 2008 Dec 9.

    PMID: 19066296RESULT

  • Janse F, Knauff EA, Niermeijer MF, Eijkemans MJ, Laven JS, Lambalk CB, Fauser BC, Goverde AJ; Dutch Premature Ovarian Failure Consortium. Similar phenotype characteristics comparing familial and sporadic premature ovarian failure. Menopause. 2010 Jul;17(4):758-65. doi: 10.1097/gme.0b013e3181cf8521.

    PMID: 20395876RESULT

  • Knauff EA, Blauw HM, Pearson PL, Kok K, Wijmenga C, Veldink JH, van den Berg LH, Bouchard P, Fauser BC, Franke L; Dutch Primary Ovarian Insufficiency Consortium. Copy number variants on the X chromosome in women with primary ovarian insufficiency. Fertil Steril. 2011 Apr;95(5):1584-8.e1. doi: 10.1016/j.fertnstert.2011.01.018. Epub 2011 Feb 12.

    PMID: 21316664RESULT

Biospecimen

Retention: SAMPLES WITH DNA

whole blood, serum and litium heparine

MeSH Terms

Conditions

Primary Ovarian Insufficiency

Condition Hierarchy (Ancestors)

Ovarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Study Officials

  • Bart CJ Fauser, MD PhD

    UMC Utrecht

    STUDY DIRECTOR

Central Study Contacts

F. Janse, MD

CONTACT

+31 88 75 55555f.janse@umcutrecht.nl

A. J. Goverde, MD, PhD

CONTACT

+31 88 75 55555a.j.goverde@umcutrecht.nl

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

August 5, 2011

First Posted

August 8, 2011

Study Start

January 1, 2005

Primary Completion

June 1, 2020

Study Completion

June 1, 2020

Last Updated

December 11, 2018

Record last verified: 2018-12

Locations

NL(1)