Ovarian Blockade During Fertility Preservation in Patients With Endometriosis

NCT06106919 | Completed

• 2 other identifiers: Local/2023/SH-012023-A02214-41
• Study Type: observational
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to demonstrate the non-inferiority of dienogest on the number of mature oocytes collected compared with "conventional" ovarian stimulation protocols (using a GnRH agonist or antagonist), in patients with endometriosis in a fertility preservation context.

Conditions

Endometriosis

Outcome Measures

Primary Outcomes (1)

• Number of mature oocytes collected by ovarian puncture

  Number of mature oocytes

  through study completion, an average of 15 days

Study Arms (3)

dienogest

Other: surveys (Fertiqol and WHOQOL-BREF)

GnRH agonist

Other: surveys (Fertiqol and WHOQOL-BREF)

GnRH antagonist

Other: surveys (Fertiqol and WHOQOL-BREF)

Interventions

surveys (Fertiqol and WHOQOL-BREF) OTHER

surveys (Fertiqol and WHOQOL-BREF)

GnRH agonist; GnRH antagonist; dienogest

Eligibility Criteria

• Age: 18 Years - 42 Years
• Sex: female
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Women of childbearing age with endometriosis who have undergone at least one cycle of ovarian stimulation for fertility preservation between June 2022 and September 2023.

You may qualify if:

• Patient aged between 18 and 42 inclusive
• Patient with endometriosis
• Patient who has undergone at least one cycle of ovarian stimulation for fertility preservation between June 2022 and September 2023 inclusive, using one of the protocols studied:
• GnRH agonist GnRH antagonist Dienogest

You may not qualify if:

• Non-medical or medical fertility preservation excluding endometriosis

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (1)

CHU de Nîmes

Nîmes, France

Location

Related Publications (1)

• Calero M, Robert J, Ranisavljevic N, Petit E, Montagut M, Lesourd F, Chevalier N, Huberlant S. Fertility preservation in women with endometriosis: A retrospective non-Inferiority study comparing Dienogest in the PPOS protocol to antagonist and agonist protocols. J Gynecol Obstet Hum Reprod. 2025 Jun;54(6):102950. doi: 10.1016/j.jogoh.2025.102950. Epub 2025 Apr 3.

  PMID: 40187738 RESULT

MeSH Terms

Conditions

Endometriosis

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2023
• First Posted: October 30, 2023
• Study Start: December 18, 2023
• Primary Completion: April 3, 2024
• Study Completion: April 3, 2024
• Last Updated: December 10, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)