Clinical trial
Impact of the Type of Treatment of the Endometrioma on Ovarian Reserve
Name
IMTERO_22
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).
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.
Trial arms
Trial start
2023-03-14
Estimated PCD
2024-11-02
Trial end
2024-11-02
Status
Recruiting
Treatment
Dienogest
Some women in the cohort will be treated with dienogest for one year after consensus with the physician
Laparoscopic cystectomy
Some women in the cohort will be treated with laparoscopic cystectomy after consensus with the physician
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
Size
100
Primary endpoint
Change in the levels of anti-Mullerian hormone
Change from baseline AMH levels at 1 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.
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': True, 'targetDuration': '1 Year', 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Serum will be stored for measurement of AMH levels in a central laboratory.'}, 'enrollmentInfo': {'count': 100, 'type': 'ESTIMATED'}}
Updated at
2023-05-16
1 organization
1 product
1 indication
Organization
University of ValenciaProduct
DienogestIndication
Endometriosis