Pheno- & Genotyping POF (WHO III)

NCT ID: NCT01411644

Last Updated: 2018-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

650 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-01-31

Study Completion Date

2020-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

First goal of the study is to phenotype patiens with hypergonadotropic ovarian dysfunction (WHO III) adequately. This group includes women with premature ovarian failure (POF), incipient ovarian failure (IOF), poor response after ovarian hyperstimulation, early menopause and hypergonadotropic primary amenorrhea. The standardized phenotyping consists of a questionnaire focusing on reproductive, medical, and family history; ultrasonography to assess ovarian reserve and/or antral follicle count and obtaining an extra blood sampling during routine endocrine screening for genotyping.

Phenotyping of patients presenting with ovarian dysfunction is of crucial importance when genotyping will be performed. The goal of this genotyping will be the identification of genetic factors associated with the (premature) depletion of the stock of ovarian follicles. It will be performed for isolated WHO III patients in an association (case-control) study for known candidate genes. In familial WHO III cases, genome wide linkage analysis will be performed.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Premature Ovarian Failure (POF) Incipient Ovarian Failure Poor Response After Ovarian Hyperstimulation Early Menopause Hypergonadotropic Amenorrhea

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

POF IOF Poor response early menopause Primary amenorrhea

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

Exclusion Criteria

* Primary amenorrhea with early development disorders causing absence of ovaries and Swyer syndrome (XY)
Minimum Eligible Age

12 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Erasmus Medical Center

OTHER

Sponsor Role collaborator

Medical Center Alkmaar

OTHER

Sponsor Role collaborator

University Medical Center Groningen

OTHER

Sponsor Role collaborator

Leiden University Medical Center

OTHER

Sponsor Role collaborator

Medisch Spectrum Twente

OTHER

Sponsor Role collaborator

Isala

OTHER

Sponsor Role collaborator

Department of Clinical Pharmacy, University Medical Centre St Radboud, The Netherlands.

OTHER

Sponsor Role collaborator

Amphia Hospital

OTHER

Sponsor Role collaborator

Deventer Ziekenhuis

OTHER

Sponsor Role collaborator

Catharina Ziekenhuis Eindhoven

OTHER

Sponsor Role collaborator

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

OTHER

Sponsor Role collaborator

Academisch Ziekenhuis Maastricht

OTHER

Sponsor Role collaborator

Amsterdam UMC, location VUmc

OTHER

Sponsor Role collaborator

UMC Utrecht

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Bart CJM Fauser

professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Bart CJ Fauser, MD PhD

Role: STUDY_DIRECTOR

UMC Utrecht

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

UMC Utrecht

Utrecht, , Netherlands

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Netherlands

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

F. Janse, MD

Role: CONTACT

Phone: +31 88 75 55555

Email: [email protected]

A. J. Goverde, MD, PhD

Role: CONTACT

Phone: +31 88 75 55555

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

F Janse, MD

Role: primary

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 19508998 (View on PubMed)

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.

Reference Type RESULT
PMID: 18551082 (View on PubMed)

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.

Reference Type RESULT
PMID: 19066296 (View on PubMed)

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.

Reference Type RESULT
PMID: 20395876 (View on PubMed)

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.

Reference Type RESULT
PMID: 21316664 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

METC 05-047

Identifier Type: -

Identifier Source: org_study_id