Overview
Sponsor-declared trial summary
Endometriosis
To assess the impact of the administration of a long-acting GnRH agonist prior to frozen embryo transfer (FET) on clinical pregnancy rates within an assisted reproductive technology (ART) protocol, in patients with endometriosis and/or adenomyosis.
Key facts
- Sponsor
- Hospital Foch
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Female
- Therapeutic area
- Diseases [C] - Female Urogenital Diseases and Pregnancy Complications [C13]
- Trial duration
- 15 Nov 2024 → ongoing
- Decision date (initial)
- 2024-11-15
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Hôpital foch
External identifiers
- EU CT number
- 2024-519126-20-00
- EudraCT number
- 2019-003645-16
- ClinicalTrials.gov
- NCT04356664
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy
To assess the impact of the administration of a long-acting GnRH agonist prior to frozen embryo transfer (FET) on clinical pregnancy rates within an assisted reproductive technology (ART) protocol, in patients with endometriosis and/or adenomyosis.
Secondary objectives 2
- Evaluate the impact of the administration of a long-acting GnRH agonist on : o Implantation rate o Miscarriage rate
- Assess the safety and tolerability of the long-acting GnRH agonist
Conditions and MedDRA coding
Endometriosis
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 6
- Women aged 18 to 36 with endometriosis and/or adenomyosis
- Having undergone IVF/ICSI with freeze-all, and for whom a blastocyst FET is planned
- A normal uterine cavity
- An MRI with contrast injection confirming endometriosis and/or adenomyosis during the inclusion visit (MRI performed after patient selection if no results from the past 6 months are available or interpretable)
- Having signed a consent form
- Affiliated with a health insurance plan
Exclusion criteria 10
- BMI > 35
- History of implantation failures (≥2)
- Endometrial abnormalities
- Known uni or bilateral hydrosalpinx
- Known hypersensitivity to GnRH, GnRH analogues, or any excipients in DECAPEPTYL® LP, 11.25 mg
- Known hypersensitivity to estradiol/progesterone/acetylsalicylic acid/folic acid/cefixime/levofloxacin
- Known or suspected breast cancer, or history of breast cancer
- Known or suspected cancer of the reproductive system, or history of reproductive system cancer
- Known or suspected estrogen-dependent malignant tumors
- Pregnancy and breast
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- The primary evaluation criterion is the clinical pregnancy rate (confirmed by the presence of a fetal heartbeat), which will be assessed in both groups during the ultrasound conducted at the final visit
Secondary endpoints 3
- Number of successful implantations per number of embryos transferred;
- Miscarriage defined as a spontaneous pregnancy loss after a successful implantation;
- Incidence and severity of side effects related to hypoestrogenism (e.g., hot flashes, night sweats, decreased libido, mood swings, etc.)
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD390677 · Product
- Active substance
- Triptorelin
- Substance synonyms
- TRIPTORELINE
- Pharmaceutical form
- PROLONGED-RELEASE SUSPENSION FOR INJECTION
- Route of administration
- INJECTION
- Max daily dose
- 11.25 mg milligram(s)
- Max total dose
- 11.25 mg milligram(s)
- Max treatment duration
- 6 Month(s)
- Authorisation status
- Authorised
- ATC code
- L02AE04 — TRIPTORELIN
- Marketing authorisation
- 34009 341 256 5 2
- MA holder
- IPSEN PHARMA
- MA country
- France
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Hospital Foch
- Sponsor organisation
- Hospital Foch
- Address
- 40 Rue Worth
- City
- Suresnes
- Postcode
- 92150
- Country
- France
Scientific contact point
- Organisation
- Hospital Foch
- Contact name
- PIRTEA Paul
Public contact point
- Organisation
- Hospital Foch
- Contact name
- PIRTEA Paul
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Authorised, recruiting | 180 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| France | 2024-11-15 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 14 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Page de signature_protocol_2024-519126-20-00 | 11 |
| Protocol (for publication) | D1_Protocol_2024-519126-20-00_SOC | 1 |
| Protocol (for publication) | D1_Protocol_2024-519126-20-00_TC | 11 |
| Protocol (for publication) | D1_Protocol_FR_2024-519126-20-00_for pub | 11 |
| Protocol (for publication) | D1_Protocol_FR_2024-519126-20-00_not for pub | 11 |
| Recruitment arrangements (for publication) | K1_ 2024-519126-20-00_Recruit arrang | 1 |
| Recruitment arrangements (for publication) | Note au dossier_Recruitment Arrangements | 1 |
| Subject information and informed consent form (for publication) | L1_2024-519126-20-00_SIS and ICF_adults__TC | 9 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_adults | 8 |
| Summary of Product Characteristics (SmPC) (for publication) | RCP_DECATEC | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | RCP-Decapeptyl_11-25 | 1 |
| Synopsis of the Protocol - Extract (for publication) | D1_Protocol synopsis_FR_2024-519126-20-00_not for pub | 11 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_FR_2024-519126-20-00_for pub | 11 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_FR_2024-519126-20-00_TC | 11 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-17 | France | Acceptable 2024-11-07
|
2024-11-15 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-06-23 | France | Acceptable 2025-07-31
|
2025-07-31 |