- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02438735
Endometrioma Related Reduced Ovarian Reserve (ERROR)
The Effect Of The Presence Of Endometriomas On Ovarian Reserve
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
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-
Turkey/bursa
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Bursa, Turkey/bursa, Kalkun
- Uludag University Scholl of medicine
-
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
The decision to include a healthy control group was taken five months after starting recruitment of women with endometrioma. Only 12 women with endometriomas had been recruited until then and none of them had six month serum AMH level measured.
Since healthy controls were reluctant to undergo transvaginal ultrasound examination, antral follicle counts were not measured as another marker of ovarian reserve for healthy controls and some women in the endometrioma group.
Beskrivelse
Inclusion Criteria:
- Reproductive age
- Endometrioma without indication for surgery or treatment with combined contraceptive, progestin or other hormonal intervention.
Exclusion Criteria:
- Menstrual cycle irregularity
- Polycystic ovarian syndrome
- Women who were pregnant or contemplating pregnancy in the next six months
- History of ovarian surgery
- Using medication which could affect ovarian function during six months before recruitment
- Indication for surgical excision
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
---|---|
Endometrioma
Reproductive aged women diagnosed with endometrioma.
Conservative follow up for six months.
|
|
Healthy Controls
Women with regular menstrual cycles and without ovarian pathology will be recruited from physicians, nurses and other staff of the same hospital. Controls will be matched for age with the women in the endometrioma group. They will be conservatively followed up for six months. |
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Historical controls who underwent surgical excision
20 women who underwent surgical excision of endometrioma in the same clinic had serum AMH levels measured preoperatively and on post operative sixth month.
Their values will be compared with that of endometrioma group.
These data were priorly published in detail (Uncu et al. 2013).
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Change in Serum Anti- mullerian hormone (AMH) level
Tidsramme: at recruitment and six months later
|
at recruitment and six months later
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studieleder: gürkan uncu, Uludag University School of Medicine
Publikationer og nyttige links
Generelle publikationer
- Uncu G, Kasapoglu I, Ozerkan K, Seyhan A, Oral Yilmaztepe A, Ata B. Prospective assessment of the impact of endometriomas and their removal on ovarian reserve and determinants of the rate of decline in ovarian reserve. Hum Reprod. 2013 Aug;28(8):2140-5. doi: 10.1093/humrep/det123. Epub 2013 Apr 26.
- Kasapoglu I, Ata B, Uyaniklar O, Seyhan A, Orhan A, Yildiz Oguz S, Uncu G. Endometrioma-related reduction in ovarian reserve (ERROR): a prospective longitudinal study. Fertil Steril. 2018 Jul 1;110(1):122-127. doi: 10.1016/j.fertnstert.2018.03.015. Epub 2018 Jun 20.
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2015-7/12
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