NCT05637073

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.

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2023

Geographic Reach
2 countries

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 22, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 5, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

March 14, 2023

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 2, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 2, 2024

Completed
Last Updated

May 16, 2023

Status Verified

May 1, 2023

Enrollment Period

1.6 years

First QC Date

October 22, 2022

Last Update Submit

May 15, 2023

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

DienogestDRUG

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

Laparoscopic cystectomyPROCEDURE

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

Control with ultrasound without other type of interventionOTHER

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

Eligibility Criteria

Age18 Years - 39 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University Hospital Poznan

Poznan, 60-355, Poland

RECRUITING

Hosp Clinico Universitario-INCLIVA

Valencia, 46010, Spain

NOT YET RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

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

MeSH Terms

Conditions

Endometriosis

Interventions

dienogestHigh-Energy Shock Waves

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

Ultrasonic WavesSoundRadiation, NonionizingRadiationPhysical Phenomena

Central Study Contacts

Antonio Cano, MD

CONTACT

+34629308479antonio.cano@uv.es

María José Fernández-Ramírez, MD

CONTACT

+34961973919mafernanrami@hotmail.com

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

November 2, 2024

Study Completion

November 2, 2024

Last Updated

May 16, 2023

Record last verified: 2023-05

Locations

ES(1)PL(1)