Clinical trial NCT05637073: Effect of Management of the Endometrioma on Ovarian Reserve
Official title: Impact of the Type of Treatment of the Endometrioma on Ovarian Reserve
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Endometrioma
Lead sponsor: University of Valencia
Sponsor class: OTHER
Collaborators: name: Hospital Comarcal Francesc de Borja Gandía, Valencia, Spain
name: Hospital Universitario San Juan de Alicante
name: Poznan University of Medical Sciences
First posted: 2022-12-05
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

Brief 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.

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/m2

Exclusion 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.

Primary outcomes:
measure: Change in the levels of anti-Mullerian hormone
timeFrame: Change from baseline AMH levels at 1 year
Secondary outcomes:
measure: Change of Pelvic pain
timeFrame: Change from baseline pelvic pain at 1 year.
measure: Change in quality of life
timeFrame: Change from baseline EHP-30 score at 1 year.
measure: Change in sexual function
timeFrame: Change from baseline FSFI score at 1 year.
measure: Change in volume of the tumor
timeFrame: Change from baseline endometrioma volume at 1 year.
measure: Satisfaction of the patient
timeFrame: Satisfaction level measured by Likert scale at 1 year.
Other outcomes:
Locations:
city: Poznan
country: Poland
facility: University Hospital Poznan
city: Valencia
country: Spain
facility: Hosp Clinico Universitario-INCLIVA
Study officials:
References: