EndometriosisPFENDONCT06106919
Ovarian Blockade During Fertility Preservation in Patients With Endometriosis
An observational study of Endometriosis, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 42 years, women only
- Conditions the study is for
- Endometriosis
- What is being tested?
- surveys (Fertiqol and WHOQOL-BREF)
- How many people
- 130 participants
- Where
- 1 siteFrance
- Study dates
- 18 Dec 2023to 3 Apr 2024
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 42 years
- Women only
- Adult
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.
Who may be able to join
- 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
Who cannot join
- -Non-medical or medical fertility preservation excluding endometriosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Endometriosis
- Being tested
- surveys (Fertiqol and WHOQOL-BREF)
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surveys (Fertiqol and WHOQOL-BREF)Other
surveys (Fertiqol and WHOQOL-BREF)
| Study group | Role | What they receive |
|---|---|---|
| dienogest | Not described Receives: Other: surveys (Fertiqol and WHOQOL-BREF) | |
| GnRH agonist | Not described Receives: Other: surveys (Fertiqol and WHOQOL-BREF) | |
| GnRH antagonist | Not described Receives: Other: surveys (Fertiqol and WHOQOL-BREF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of mature oocytes collected by ovarian puncture
Number of mature oocytes
Measured: through study completion, an average of 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2023
- Study start18 Dec 2023
- Primary completion3 Apr 2024
- Study completion3 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 130 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06106919
- Sponsor's protocol ID
- Local/2023/SH-01
- Other IDs
- 2023-A02214-41
- Acronym
- PFENDO
- Status last verified
- Dec 2025
- First submitted
- 20 Oct 2023
- Last updated
- 10 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40187738
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PFENDO : Ovarian Blockade During Fertility Preservation in Patients With Endometriosis: a Retrospective Non-inferiority Comparative Study
- ClinicalTrials.gov ID
- NCT06106919
- Acronym / sponsor ID
- PFENDO / Local/2023/SH-01
- Conditions
- Endometriosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 18 Dec 2023 (actual)
- Primary completion
- 3 Apr 2024 (actual)
- Study completion
- 3 Apr 2024 (actual)
- First posted
- 30 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| dienogest | – | Other: surveys (Fertiqol and WHOQOL-BREF) |
| GnRH agonist | – | Other: surveys (Fertiqol and WHOQOL-BREF) |
| GnRH antagonist | – | Other: surveys (Fertiqol and WHOQOL-BREF) |
Who may qualify
- Ages
- 18 to 42 years
- Sex
- Female only
- Age groups
- Adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- -Non-medical or medical fertility preservation excluding endometriosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| surveys (Fertiqol and WHOQOL-BREF)surveys (Fertiqol and WHOQOL-BREF) | Other | GnRH agonist, GnRH antagonist, dienogest |
Primary outcome
Number of mature oocytes collected by ovarian puncture
Time frame: through study completion, an average of 15 days
Number of mature oocytes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2025.
- Results publication: PubMed 40187738Calero 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endometriosis, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of mature oocytes collected by ovarian puncture (time frame: through study completion, an average of 15 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06106919, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2025.