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Effect of Management of the Endometrioma on Ovarian Reserve

NCT05637073 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2023-05-16

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Hospital Comarcal Francesc de Borja Gandía, Valencia, Spain

    collaborator UNKNOWN

  • Hospital Universitario San Juan de Alicante

    collaborator OTHER

  • Poznan University of Medical Sciences

    collaborator OTHER

  • University of Valencia

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
39 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-14
Primary Completion
2024-11-02
Completion
2024-11-02
FDA Drug
Yes

Countries

  • Poland
  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05637073 on ClinicalTrials.gov