Effect of Management of the Endometrioma on Ovarian Reserve

Endometrioma Clinical Trial

— IMTERO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05637073
• Other study ID #: IMTERO_22
• Status: Recruiting
• 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
• 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.

Related Conditions & MeSH terms

• Endometrioma
• Endometriosis

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.