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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05637073
Other study ID # IMTERO_22
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 14, 2023
Est. completion date November 2, 2024

Study information

Verified date May 2023
Source University of Valencia
Contact Antonio Cano, MD
Phone +34629308479
Email antonio.cano@uv.es
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date November 2, 2024
Est. primary completion date November 2, 2024
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 39 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Poland University Hospital Poznan Poznan
Spain Hosp Clinico Universitario-INCLIVA Valencia

Sponsors (4)

Lead Sponsor Collaborator
University of Valencia Hospital Comarcal Francesc de Borja Gandía, Valencia, Spain, Hospital Universitario San Juan de Alicante, Poznan University of Medical Sciences

Countries where clinical trial is conducted

Poland,  Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in the levels of anti-Mullerian hormone Ovarian reserve as measured by the levels of AMH Change from baseline AMH levels at 1 year
Secondary 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. Change from baseline pelvic pain at 1 year.
Secondary 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. Change from baseline EHP-30 score at 1 year.
Secondary 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. Change from baseline FSFI score at 1 year.
Secondary Change in volume of the tumor Measured by ultrasound, in the case of the two non-surgical approaches Change from baseline endometrioma volume at 1 year.
Secondary 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. Satisfaction level measured by Likert scale at 1 year.
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