An observational study in Endometrioma, sponsored by University of Valencia. Withdrawn at 2 sites in 2 countries. Open to female participants aged 18 Years to 39 Years. Per ClinicalTrials.gov, last updated 2026-07-08.
Sponsored by University of Valencia · Observational
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.
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).
Secondary objectives were the comparison of the effect on i) pelvic pain, including dysmenorrhea, non-menstrual pelvic pain, deep dyspareunia, or dyschezia, ii) other symptoms including menorrhagia, gastrointestinal symptoms different to dyschezia, or urinary symptoms; iii) quality of life as assessed by the EHP-30 questionnaire; iv) sexual functions, as assessed the female sexual function index (FSFI); v) progression in the size of the tumor in the case of the two non-surgical approaches; vi) impact on work productivity and activity impairment; vii) satisfaction in the patient.
A prospective assessment will be performed on a cohort of women with endometrioma diagnosed by ultrasound from diagnosis for up to one year. The assignment to each management option will be performed under usual care conditions so that the selected option will result from the shared clinical decision of the clinician with the patient.
The target population will be composed of 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/m2.
Participants will be controlled at 3 months, 6 months and one year.
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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/m2.
Exclusion Criteria:
Some women in the cohort will be treated with dienogest for one year after consensus with the physician
Some women in the cohort will be treated with laparoscopic cystectomy after consensus with the physician
Some women in the cohort will be followed with ultrasound control, without other intervention, after consensus with the physician
Change in the levels of anti-Mullerian hormone
Ovarian reserve as measured by the levels of AMH
Time frame: Change from baseline AMH levels at 1 year
Change of Pelvic pain
Dysmenorrhea, non-menstrual pelvic pain, deep dyspareunia, or dyschezia measured by a visual analogue scale from 0 to 5 and in which higher score means worse outcome.
Time frame: Change from baseline pelvic pain at 1 year.
Change in quality of life
Assessed by the Endometriosis Health Profile-30 (EHP-30) questionnaire, in which the minimum score is 0 and the highest 150. Higher score means a worse outcome.
Time frame: Change from baseline EHP-30 score at 1 year.
Change in sexual function
Assessed the female sexual function index (FSFI) questionnaire in which there are 6 questions from 0 to 5. The highest score is 30 and the lowest 0. Lower score means worse outcome.
Time frame: Change from baseline FSFI score at 1 year.
Change in volume of the tumor
Measured by ultrasound, in the case of the two non-surgical approaches
Time frame: Change from baseline endometrioma volume at 1 year.
Satisfaction of the patient
Satisfaction as assessed by a Likert scale in which the score is from 0 to 5 in which higher score means better outcome.
Time frame: Satisfaction level measured by Likert scale at 1 year.
Plan to share: Undecided
No publications or documents are linked to this record.
This study is withdrawn, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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University of Valencia