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Onderzoek naar het effect van hormoonbehandeling op de eierstokken


- candidate number19413
- NTR NumberNTR4784
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR9-sep-2014
- Secondary IDs2014.402 METC VUmc
- Public TitleOnderzoek naar het effect van hormoonbehandeling op de eierstokken
- Scientific TitleEffect of supraphysiological androgen treatment on ovaries
- ACRONYM
- hypothesisLong term androgen treatment in female-to-male transsexuals (FtMs) leads to changes in the ovaries: polycystic ovaries, determined by transvaginal ultrasound and histopathology.
So the aim of this study is to determine wether long-term high doses of exogenous androgens affect ovarian morphology. In terms of: 1. transvaginal ultrasound and 2. histopathological features.
- Healt Condition(s) or Problem(s) studiedAndrogens, Ovary
- Inclusion criteria- Diagnosis Gender Dysphoria
- >1 year cross-sex hormonal treatment
- Age 18+
- Intention to undergo sex-reassignment surgery
- Exclusion criteria- Disorder of sexual development
- Concomitant pathology with known or possible endocrine effects
- Excessive alcohol or drug abuses
- Patients who explicitly declare that they do not want to participate in the study
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- Type[default]
- Studytypeobservational
- planned startdate 20-aug-2014
- planned closingdate20-mrt-2016
- Target number of participants50
- InterventionsStandard androgenic treatment as part of their sex-reassignment hormonal therapy.
- Primary outcomeOvarian morphology, in terms of:
- transvaginal ultrasound
- histopathological features
- Secondary outcomePredisposition towards hyperandrogenism and reproductive alterations in gender dysphoric (GD) individuals, and are polycystic ovaries more likely in GD females?
- TimepointsT = 0: start androgenic treatment
T = 1: operation day (minimum of 12 months after start treatment)
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIESDrs. M.R. Caanen
- CONTACT for SCIENTIFIC QUERIESDr. C.B. Lambalk
- Sponsor/Initiator VU University Medical Center, Department of Obstetrics and Gynaecology
- Funding
(Source(s) of Monetary or Material Support)
Stichting Wetenschappelijk Onderzoek Gynaecologie (SWOG)
- Publicationsna.
- Brief summaryProspective observational cohort study.
The aim of this study is to examine the ovarian effects of long-term androgen treatment in gender dysphoric females. This will enable us to provide: 1. adequate care for FtMs concerning their inner genitalia, especially ovaries and 2. provide more insight in the pathophysiologic mechanism of PCOS. Standard androgenic treatment or surgery as part of their sex-reassigment hormonal therapy will not be influenced. Morphologic changes of ovaries will be determined by transvaginal ultrasound and histopathology.
- Main changes (audit trail)
- RECORD9-sep-2014 - 10-okt-2014


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