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NCT05637073
Effect of Management of the Endometrioma on Ovarian Reserve
Conditions: Endometrioma
Sex: Female
Ages: 18 Years – 39 Years
Enrollment: 100
Sponsor: University of Valencia
Location: Spain
Summary
Investigators aimed at comparing the impact on ovarian reserve of three usual-care management options of endometrioma, laparoscopic cystectomy (LC), hormonal treatment with daily dienogest (HT), or mere ultrasound control (UC).Ovarian reserve will be measured by the effect on the circulating levels of anti-Mullerian hormone (AMH).
Secondary objectives will be effect on pelvic pain, other symptoms, sexual function, quality of life, progression in size of the endometrioma, impact on work productivity and activity impairment, and satisfaction with treatment.Participants will be followed by up to one year.
Eligibility Criteria
Inclusion Criteria:Caucasian premenopausal women between 18-39 years with the diagnosis of endometrioma, one or more, with a diameter of up to 7 cm by endovaginal ultrasound.
Body mass index comprised between 17-30 Kg/m2Exclusion Criteria:Previous ovarian surgery;Previous pathologies involving the ovary, including other ovarian tumors, polycystic ovaries, or pelvic inflammatory disease;Previous diagnosis of cancer treated with chemotherapy or local radiotherapy;Diseases affecting the endocrine system, diabetes, thyroid, hyperprolactinemia, or the immune system (lupus, Crohn,…);Genesic wish;Endometrioma >7 cm;Unhealthy habits, including smoking, alcohol consumption above social level, or illicit drugs;Insufficient level of autonomy for unrestrictedly signing informed consent;Current or previous use of hormonal contraceptives, Gonadotropin-Releasing Hormone (GnRH) analogues, any drug with a known effect on endometriosis, or any drug under investigation, for what a washing up period of 6 months will be required in all cases.
Source: ClinicalTrials.gov (NCT05637073). StuddyBuddy aggregates publicly available trial information.