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Menstruatie(stoornissen) in de puberteit: het vervolg


- candidate number24402
- NTR NumberNTR5871
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR26-mei-2016
- Secondary IDs2016.169 METc Vumc 
- Public TitleMenstruatie(stoornissen) in de puberteit: het vervolg
- Scientific TitlePubertal onset of menstrual cycle abnormalities: the follow-up
- ACRONYMPOMP: the follow-up
- hypothesisRationale: Irregular menstrual cycles during puberty have been considered part of development, explained by incomplete maturation of the hypothalamic-pituitary ovarian axis. A distinction between developmental and pathological causes of abnormal menstrual cycle patterns in adolescents is meaningful as pathologic causes - especially polycystic ovary syndrome - may be associated with subfertility, due to ovulatory dysfunction later in life, and long-term health risks concerning metabolic and cardiovascular health. To study the relationship between adolescent cycle abnormalities and the development of young adult ovulatory dysfunction presenting as oligomenorrhoea or normogonadotropic amenorrhoea, comprehensive data was collected prospectively between 1990-1997 from 294 adolescent girls in ‘The POMP study’ (Pubertal Onset of Menstrual cycle abnormalities, a Prospective study). This study was performed by the division of Reproductive Medicine from the VU University Medical Center (VUMC) in collaboration with the Youth Health services from Amstelland – de Meerlanden, Amstelveen, The Netherlands. Because data in this field are scarce, combining data collected in this adolescent study with information obtained from these individuals as adults in this follow-up study, may provide valuable and unique data.This follow-up study can help to elucidate the relation between cycle irregularities at adolescence and the diagnosis of polycystic ovary syndrome in adulthood presenting with with subfertility, metabolic and cardiovascular health risks. In the future adolescents at risk that are identified, may benefit from solid education and lifestyle adaptation. Therefore a distinction between developmental and pathologic causes of abnormal menstrual cycle patterns is meaningful.
Objective: The aim of this study is to estimate the association of menstrual cycle pattern combined with body and endocrine characteristics in adolescence (age 15-18 years) and presentation of polycystic ovary syndrome in adulthood.
- Healt Condition(s) or Problem(s) studiedMenstrual cycle, Menstrual cycle (irregularities), Polycystic ovary syndrome (PCOS)
- Inclusion criteriaParticipants of Original POMP study.
- Exclusion criteria-
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlNot applicable
- group[default]
- Type[default]
- Studytypeobservational
- planned startdate 26-mei-2016
- planned closingdate26-mei-2018
- Target number of participants
- InterventionsQuestionnaire
- Primary outcomeTo estimate the predictive value of menstrual cycle pattern in adolescence (age 15-18 years) and presentation of polycystic ovary syndrome and polycystic ovary syndrome related subfertility, diabetes type II and cardiovascular health problems in adulthood.
- Secondary outcomeTo estimate the predictive value of various combinations of menstrual cycle pattern, clinical and/or biochemical signs of hyperandrogenism and ultrasound pattern of the ovaries in adolescence (age 15-18 years) for
- Menstrual cycle pattern/disturbances in adulthood
- Fertility history/performance/treatment
- Time to pregnancy, outcome of pregnancies
- Metabolic and cardiovascular health problems/risk factors
- Timepointsna
- Trial web sitena
- statusopen: patient inclusion
- 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)
None
- Publicationsvan Hooff MH, Voorhorst FJ, Kaptein MB, Hirasing RA, Koppenaal C, Schoemaker J. Polycystic ovaries in adolescents and the relationship with menstrual cycle patterns, luteinizing hormone, androgens, and insulin. Fertil Steril 2000 Jul;74(1):49-58.

van Hooff MH, Voorhorst FJ, Kaptein MB, Hirasing RA, Koppenaal C, Schoemaker J. Insulin, androgen, and gonadotropin concentrations, body mass index, and waist to hip ratio in the first years after menarche in girls with regular menstrual cycles, irregular menstrual cycles, or oligomenorrhea. J Clin Endocrinol Metab 2000 Apr;85(4):1394-400.

van Hooff MH, Voorhorst FJ, Kaptein MB, Hirasing RA, Koppenaal C, Schoemaker J. Endocrine features of polycystic ovary syndrome in a random population sample of 14-16 year old adolescents. Hum Reprod 1999 Sep;14(9):2223-9.

van Hooff MH, van der Meer M, Lambalk CB, Schoemaker J. Variation of luteinizing hormone and androgens in oligomenorrhoea and its implications for the study of polycystic ovary syndrome. Hum Reprod 1999 Jul;14(7):1684-9.

van Hooff MH, Hirasing RA, Kaptein MB, Koppenaal C, Voorhorst FJ, Schoemaker J. The use of oral contraceptives by adolescents for contraception, menstrual cycle problems or acne. Acta Obstet Gynecol Scand 1998 Oct;77(9):898-904. van Hooff MH, Voorhorst FJ, Kaptein MB, Hirasing RA, Koppenaal C, Schoemaker J. Relationship of the menstrual cycle pattern in 14-17 year old old adolescents with gynaecological age, body mass index and historical parameters. Hum Reprod 1998 Aug;13(8):2252-60.
- Brief summaryIrregular menstrual cycles during puberty have been considered part of development, explained by incomplete maturation of the hypothalamic-pituitary ovarian axis. A distinction between developmental and pathological causes of abnormal menstrual cycle patterns in adolescents is meaningful as pathologic causes - especially polycystic ovary syndrome - may be associated with subfertility, due to ovulatory dysfunction later in life, and long-term health risks concerning metabolic and cardiovascular health. To study the relationship between adolescent cycle abnormalities and the development of young adult ovulatory dysfunction presenting as oligomenorrhoea or normogonadotropic amenorrhoea, comprehensive data was collected prospectively between 1990-1997 from 294 adolescent girls in ‘The POMP study’ (Pubertal Onset of Menstrual cycle abnormalities, a Prospective study). This study was performed by the division of Reproductive Medicine from the VU University Medical Center (VUMC) in collaboration with the Youth Health services from Amstelland – de Meerlanden, Amstelveen, The Netherlands. Because data in this field are scarce, combining data collected in this adolescent study with information obtained from these individuals as adults in this follow-up study, may provide valuable and unique data.This follow-up study can help to elucidate the relation between cycle irregularities at adolescence and the diagnosis of polycystic ovary syndrome in adulthood presenting with with subfertility, metabolic and cardiovascular health risks. In the future adolescents at risk that are identified, may benefit from solid education and lifestyle adaptation. Therefore a distinction between developmental and pathologic causes of abnormal menstrual cycle patterns is meaningful.
This observational, prospective, cohort follow-up study contains a questionnaire, including the following subjects: general health, menstrual cycle pattern, fertility history/performance and pregnancy outcome.
Main study parameters/endpoints: Polycystic ovary syndrome associated subfertility due to ovulation dysfunction and PCOS associated metabolic and cardiovascular health problems.
- Main changes (audit trail)
- RECORD26-mei-2016 - 2-jul-2016


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