Effect of Management of the Endometrioma on Ovarian Reserve (IMTERO)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Endometrioma
• Intervention / Treatment: Drug: Dienogest; Procedure: Laparoscopic cystectomy; Other: Control with ultrasound without other type of intervention

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.

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Antonio Cano, MD; Phone Number: +34629308479; Email: antonio.cano@uv.es
• Study Contact Backup: Name: María José Fernández-Ramírez, MD; Phone Number: +34961973919; Email: mafernanrami@hotmail.com

Study Locations

• Poland
  • Poznan, Poland, 60-355
    • Recruiting
    • University Hospital Poznan
    • Contact: Blazej Meczekalski, Prof; Phone Number: +48 61 669 82 22
• Spain
  • Valencia, Spain, 46010
    • Not yet recruiting
    • Hosp Clinico Universitario-INCLIVA
    • Contact: Antonio Cano Sánchez, MD; Phone Number: 961973500; Email: antonio.cano@uv.es
    • Contact: C

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 39 years (Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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.
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.
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.

Collaborators and Investigators

• Sponsor: University of Valencia
• Collaborators: Poznan University of Medical Sciences; Hospital Universitario San Juan de Alicante; Hospital Comarcal Francesc de Borja Gandía, Valencia, Spain

Study record dates

Study Major Dates

• Study Start (Actual): March 14, 2023
• Primary Completion (Anticipated): November 2, 2024
• Study Completion (Anticipated): November 2, 2024

Study Registration Dates

• First Submitted: October 22, 2022
• First Submitted That Met QC Criteria: November 23, 2022
• First Posted (Actual): December 5, 2022

Study Record Updates

• Last Update Posted (Actual): May 16, 2023
• Last Update Submitted That Met QC Criteria: May 15, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endometriosis; Physiological Effects of Drugs; Antineoplastic Agents; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Hormone Antagonists; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Contraceptives, Oral; Contraceptive Agents, Female; Contraceptives, Oral, Hormonal; Contraceptive Agents, Male; Dienogest
• Other Study ID Numbers: IMTERO_22

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No