Ovarian Blockade During Fertility Preservation in Patients With Endometriosis (PFENDO)

February 19, 2024 updated by: Centre Hospitalier Universitaire de Nīmes

PFENDO : Ovarian Blockade During Fertility Preservation in Patients With Endometriosis: a Retrospective Non-inferiority Comparative Study

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Endometriosis is a common pathology affecting 1 in 10 women of childbearing age, and is responsible for around 40% of infertility cases.

The impact of endometriosis on fertility has now been clearly demonstrated, making it a medical indication for fertility preservation.

Today, dienogest is a key element in the therapeutic arsenal, helping to alleviate painful symptoms, reduce endometriosis lesions and improve patients' quality of life.

By creating a hypo-oestrogenic and hyperprogestogenic climate, dienogest at a daily dose of 2mg not only atrophies the endometrial tissue of endometriotic lesions, but also inhibits ovulation, enabling it to be used as an adjuvant treatment to ovarian stimulation.

There are currently 3 protocols commonly used during ovarian stimulation for oocyte self-preservation: the antagonist protocol (using a GnRH antagonist), the agonist protocol (using a GnRH agonist) and the PPOS protocol (using a progestin, which may be dienogest). In patients undergoing long-term dienogest therapy, the first 2 protocols require discontinuation of background treatment, which entails a risk of recurrence of symptoms and progression of endometriosis lesions, unlike the PPOS protocol, which allows dienogest treatment to be continued during stimulation.

A few studies have looked at progestin blockade of ovulation during ovarian stimulation and found no negative impact on the number of oocytes collected, compared with commonly used protocols (antagonist or agonist protocol). However, these studies do not concern blocking with dienogest, a progestin whose use has recently been extended due to the generic drug's marketing authorization obtained in 2019.

Ovarian stimulation with dienogest has therefore received very little attention in the literature. The only study on this subject is a prospective study comparing dydrogesterone and dienogest during ovarian stimulation for IVF. The number of mature oocytes collected was significantly lower in the dienogest group, but the 2 groups were not comparable, particularly in terms of AMH and CFA, which were significantly lower in the dienogest group, making the results difficult to interpret.

Further studies therefore seem necessary to investigate the impact of dienogest blockade on ovarian response, given the benefits brought by this treatment in terms of ease of use and clinical tolerance in patients with endometriosis.

Study Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

N/A

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.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

-Non-medical or medical fertility preservation excluding endometriosis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
dienogest
Other: surveys (Fertiqol and WHOQOL-BREF)
surveys (Fertiqol and WHOQOL-BREF)
GnRH agonist
Other: surveys (Fertiqol and WHOQOL-BREF)
surveys (Fertiqol and WHOQOL-BREF)
GnRH antagonist
Other: surveys (Fertiqol and WHOQOL-BREF)
surveys (Fertiqol and WHOQOL-BREF)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of mature oocytes collected by ovarian puncture
Time Frame: through study completion, an average of 15 days
Number of mature oocytes
through study completion, an average of 15 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Nīmes

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 18, 2023

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

October 20, 2023

First Submitted That Met QC Criteria

October 26, 2023

First Posted (Actual)

October 30, 2023

Study Record Updates

Last Update Posted (Estimated)

February 21, 2024

Last Update Submitted That Met QC Criteria

February 19, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Local/2023/SH-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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