Premature Ovarian Failure (POF)NCT01411644
Pheno- & Genotyping POF (WHO III)
An observational study of Premature Ovarian Failure (POF) and Incipient Ovarian Failure, run by UMC Utrecht at 1 site in Netherlands.
Trial summary
This study focuses on the phenotyping and genotyping of women with hypergonadotropic ovarian dysfunction (WHO III status). Read more about this study
- Who is it for?
- Ages 12 years and older, women only
- Conditions the study is for
- Premature Ovarian Failure (POF), Incipient Ovarian Failure, Poor Response After Ovarian Hyperstimulation
- How many people
- 650 participants
- Where
- 1 siteNetherlands
- Study dates
- Jan 2005to Jun 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Women with WHO III status who attend the outpatient clinic of participating hospitals.
Who may be able to join
- 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
Who cannot join
- Primary amenorrhea with early development disorders causing absence of ovaries and Swyer syndrome (XY)
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
UMC Utrecht
Utrecht, 3508 GA
F Janse, MD, +31 88 755 5555 ext. 53629, f.janse@umcutrecht.nl
About this study
Official title: Phenotyping and Genotyping of Women Presenting With Ovarian Dysfunction Associated With a Hypergonadotropic Hypo-estrogenic Hormonal Status (WHO III) and Their First and Second Degree Relatives
This study focuses on the phenotyping and genotyping of women with hypergonadotropic ovarian dysfunction (WHO III status).
Read the detailed description
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
- Premature Ovarian Failure (POF), Incipient Ovarian Failure, Poor Response After Ovarian Hyperstimulation, Early Menopause, Hypergonadotropic Amenorrhea
- Keywords
- POF, IOF, Poor response, early menopause, Primary amenorrhea
- Medical subject headings
- Primary Ovarian Insufficiency
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2011 (estimated)
- Study startJan 2005
- Primary completionJun 2020 (estimated)
- Study completionJun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Premature Ovarian Failure (POF)Studies of the same condition, open and under way.
- More trials run by UMC UtrechtThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 650 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Collaborators
- Erasmus Medical Center, Medical Center Alkmaar, University Medical Center Groningen, Leiden University Medical Center, Medisch Spectrum Twente, Isala, Department of Clinical Pharmacy, University Medical Centre St Radboud, The Netherlands., Amphia Hospital, Deventer Ziekenhuis, Catharina Ziekenhuis Eindhoven, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Academisch Ziekenhuis Maastricht, Amsterdam UMC, location VUmc
- Responsible party
- Principal investigator, Bart CJM Fauser, UMC Utrecht
- Investigators
- Bart CJ Fauser, MD PhD, Study director, UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01411644
- Sponsor's protocol ID
- METC 05-047
- Status last verified
- Dec 2018
- First submitted
- 5 Aug 2011
- Last updated
- 11 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 19508998Knauff 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.
PubMed 18551082Knauff 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.
PubMed 19066296Janse 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.
PubMed 20395876Knauff 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.
PubMed 21316664
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phenotyping and Genotyping of Women Presenting With Ovarian Dysfunction Associated With a Hypergonadotropic Hypo-estrogenic Hormonal Status (WHO III) and Their First and Second Degree Relatives
- ClinicalTrials.gov ID
- NCT01411644
- Acronym / sponsor ID
- METC 05-047
- Conditions
- Premature Ovarian Failure (POF), Incipient Ovarian Failure, Poor Response After Ovarian Hyperstimulation, Early Menopause, Hypergonadotropic Amenorrhea
- Keywords
- POF, IOF, Poor response, early menopause, Primary amenorrhea
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 650 participants (estimated)
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Collaborators
- Erasmus Medical Center, Medical Center Alkmaar, University Medical Center Groningen, Leiden University Medical Center, Medisch Spectrum Twente, Isala, Department of Clinical Pharmacy, University Medical Centre St Radboud, The Netherlands., Amphia Hospital, Deventer Ziekenhuis, Catharina Ziekenhuis Eindhoven, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Academisch Ziekenhuis Maastricht, Amsterdam UMC, location VUmc
- Study start
- Jan 2005
- Primary completion
- Jun 2020 (estimated)
- Study completion
- Jun 2020 (estimated)
- First posted
- 8 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study focuses on the phenotyping and genotyping of women with hypergonadotropic ovarian dysfunction (WHO III status).
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 12 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Women with WHO III status who attend the outpatient clinic of participating hospitals.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Primary amenorrhea with early development disorders causing absence of ovaries and Swyer syndrome (XY)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2018.
- Background: PubMed 19508998Knauff 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.
- Results publication: PubMed 18551082Knauff 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.
- Results publication: PubMed 19066296Knauff 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.
- Results publication: PubMed 20395876Janse 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.
- Results publication: PubMed 21316664Knauff 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bart CJ Fauser, MD PhD study director
UMC Utrecht
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Premature Ovarian Failure (POF) and Incipient Ovarian Failure, run by UMC Utrecht at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact F. Janse, MD (+31 88 75 55555 ext. 53629, f.janse@umcutrecht.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01411644, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2018.