Effect of Management of the Endometrioma on Ovarian Reserve

NCT05637073 | Withdrawn FDA Drug

• 1 other identifier: IMTERO_22
• Study Type: observational
• Target: N/A
• Locations: 2 countries
• Sites: 2

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.

Conditions

Endometrioma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Change of Pelvic pain

  Change from baseline pelvic pain at 1 year.

• Change in quality of life

  Change from baseline EHP-30 score at 1 year.

• Change in sexual function

  Change from baseline FSFI score at 1 year.

• Change in volume of the tumor

  Change from baseline endometrioma volume at 1 year.

• Satisfaction of the patient

  Satisfaction level measured by Likert scale at 1 year.

Interventions

Dienogest DRUG

Some women in the cohort will be treated with dienogest for one year after consensus with the physician

Laparoscopic cystectomy PROCEDURE

Some women in the cohort will be treated with laparoscopic cystectomy after consensus with the physician

Control with ultrasound without other type of intervention OTHER

Some women in the cohort will be followed with ultrasound control, without other intervention, after consensus with the physician

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (2)

University Hospital Poznan

Poznan, Poznan, 60-355, Poland

Location

Hosp Clinico Universitario-INCLIVA

Valencia, Valencia, 46010, Spain

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum will be stored for measurement of AMH levels in a central laboratory.

MeSH Terms

Conditions

Endometriosis

Interventions

dienogest; High-Energy Shock Waves

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Obstetrics & Gynecology

Study Record Dates

• First Submitted: October 22, 2022
• First Posted: December 5, 2022
• Study Start: March 14, 2023
• Primary Completion: June 2, 2026
• Study Completion (Estimated): November 2, 2026
• Last Updated: July 8, 2026

Record last verified: 2026-07

Locations

PL (1); ES (1)