NCT05637073

Effect of Management of the Endometrioma on Ovarian Reserve

Impact of the Type of Treatment of the Endometrioma on Ovarian Reserve

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: University of Valencia · Academic / Other
• Sex: Female
• Age: 18 Years – 39 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Endometrioma

Interventions

Type	Name	Description
DRUG	Dienogest	Some women in the cohort will be treated with dienogest for one year after consensus with the physician
PROCEDURE	Laparoscopic cystectomy	Some women in the cohort will be treated with laparoscopic cystectomy after consensus with the physician
OTHER	Control with ultrasound without other type of intervention	Some women in the cohort will be followed with ultrasound control, without other intervention, after consensus with the physician

Timeline

• Start date: 2023-03-14
• Primary completion: 2024-11-02
• Completion: 2024-11-02
• First posted: 2022-12-05
• Last updated: 2023-05-16

Locations

2 sites across 2 countries: Poland, Spain

Regulatory

• FDA-regulated drug study