Ovarian Reserve Following Medical Therapy in Patients With Endometriosis

NCT06799754 | Completed

• 1 other identifier: EndoAMH
• Study Type: observational
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to investigate whether there is an effect on ovarian reserve from medical therapy for endometriosis. Although the therapeutic efficacy of medical hormone therapy on ovarian endometriosis has been proven in many scientific studies, none of these has shown an effect on ovarian reserve. The aim of this study is to investigate whether there is a difference in ovarian reserve as measured by biochemical and ultrasound parameters before and after therapy.

Conditions

Endometriosis

Keywords

endometriosis; medical therapy; ovarian reserve

Outcome Measures

Primary Outcomes (1)

• Ovarian reserve in patients with ovarian endometriosis

  Evaluate the ovarian reserve at ultrasound and biochemical level in patients with ovarian endometriosis treated with medical therapy

  Through study completion, an average of 4 years

Secondary Outcomes (3)

• Follicle stimulating hormone (FSH)

  Through study completion, an average of 4 years

• Ultrasound assessment of ovarian volume and endometriosis cyst volume

  Through study completion, an average of 4 years

• Ovarian reserve in patients with concomitant deep endometriosis compared to those with ovarian endometriosis alone

  Through study completion, an average of 4 years

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with ovarian endometriosis desiring pregnancy with or without concomitant deep endometriosis

You may qualify if:

• Clinical and ultrasound diagnosis of ovarian endometriosis without indication for surgery
• Age between 18 and 40 years
• Patients desiring pregnancy
• Informed consent obtained

You may not qualify if:

• Endocrinological disorders (including thyroid dysfunction, hyperprolactinaemia and Cushing's syndrome)
• Previous ovarian surgery
• Suspected cyst malignancy

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, Bologna, 40138, Italy

Location

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

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

Study Officials

• Renato Seracchioli, MD

  IRCCS Azienda Ospedaliero-Universitaria di Bologna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2024
• First Posted: January 29, 2025
• Study Start: July 19, 2020
• Primary Completion: January 31, 2023
• Study Completion: November 18, 2024
• Last Updated: January 29, 2025

Record last verified: 2024-11

Locations

IT (1)