EndometriosisPhase 2/3DECATECNCT04356664
Benefit of GnRH Agonist Before Frozen Embryo Transfer in Patients With Endometriosis and/or Adenomyosis
A Phase 2/3 study testing GnRH agonist in people with Endometriosis and Adenomyosis, run by Hopital Foch at 1 site in France.
Trial summary
Women suffering from endometriosis and/or adenomyosis may also suffer from infertility. GnRH agonist injection could improve implantation and therefore increase the pregnancy rate in these patients. Read more about this study
- Who is it for?
- Ages 18 to 36 years, women only
- Conditions the study is for
- Endometriosis, Adenomyosis, Infertility, Female
- What is being tested?
- GnRH agonist
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteFrance
- Study dates
- 18 Mar 2021to 18 Jun 2026
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
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 36 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women aged 18 to 36 years (women ≥18 years to <36 years) with endometriosis and / or adenomyosis
- Having benefited from In vitro fertilisation /intracytoplasmic micro-injection with freeze all and for whom the frozen embryon transfer of a blastocyst is planned
- A normal uterine cavity
- An MRI showing endometriosis and / or adenomyosis during the inclusion visit
- Having signed a consent form
- Being affiliated to a Health Insurance Plan.
Who cannot join
- Patient aged <18 years and ≥ 36 years
- BMI> 35
- History of implantation failures (≥ 2)
- Endometrial alterations: synechiae, polyps, myomas, hyperplasia, hematometra
- known hydrosalpinx uni or bilateral
- MRI showing no endometriosis or adenomyosis
Show all 31Show fewer
- Hypersensitivity to GnRH, GnRH analogues, or any of the excipients of Decapeptyl 3 mg
- Known hypersensitivity to estradiol
- Known hypersensitivity to progesterone
- Known hypersensitivity to acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs
- Known hypersensitivity to folic acid
- Known hypersensitivity to cefixime or an antibiotic in the cephalosporin group
- Known hypersensitivity to levofloxacin or any other quinolone
- History of tendinopathies related to the administration of fluoroquinolones
- Epilepsy
- Hypersensitivity to contrast agents for MRI
- Known or suspected breast cancer or history of breast cancer
- Known or suspected genital tract cancer or history of genital cancer
- known or suspected estrogen-dependent malignant neoplasms
- Undiagnosed genital haemorrhage
- Untreated endometrial hyperplasia
- History of idiopathic venous thrombo-embolic accident or evolving venous thrombo-embolic event (deep vein thrombosis, pulmonary embolism)
- Recent or evolving arterial thromboembolic stroke (eg angina, myocardial infarction)
- Acute liver disease or history of liver disease, until hepatic tests are normalized
- Severe renal insufficiency
- Severe, uncontrolled heart failure
- Evolutionary gastroduodenal ulcer
- History of asthma caused by the administration of salicylates or substances of similar activity, especially nonsteroidal anti-inflammatory drugs
- GnRH Agonist Decapeptyl administered within 6 months prior to transfer
- To be deprived of liberty or under guardianship
- Pregnancy and breast feeding.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hopital Foch
Suresnes, 92150
Paul Pirtea, +331 46 25 35 20, p.pirtea@hopital-foch.com
About this study
Official title: Benefit of Gonadotropin-releasing Hormone (GnRH) Agonist Before Frozen Embryo Transfer in Patients With Endometriosis and / or Adenomyosis: Randomized Prospective Study
Women suffering from endometriosis and/or adenomyosis may also suffer from infertility. GnRH agonist injection could improve implantation and therefore increase the pregnancy rate in these patients. This study was designed to evaluate effects of the additional of GnRH agonist (single or 2 doses) to the routine oestrogens and progestins use as support before Frozen Embryon Transfer as compared to oestrogens and progestins only.
Read the detailed description
Endometriosis reveals the presence of glands or endometrial stroma outside the uterus, responsible for pain and infertility. Adenomyosis illustrates an invagination of endometrial islets within the myometrium, leading to a disturbance of its contractile activity, also potentiated by local hyperestrogenism.
These two pathologies are often associated, and express an alteration of the eutopic endometrium by pro-inflammatory markers responsible for a lower implantation rate.
GnRH agonists are known to decrease these pro-inflammatory markers (cytochrome P450 and Cox 2 aromatase) in the eutopic endometrium of women with endometriosis or adenomyosis.
Patients will received 1 or 2 injection of GnRH delay agonist (Decapeptyl 3mg) approximately 1 month before the frozen embryo transfer.
- Conditions
- Endometriosis, Adenomyosis, Infertility, Female
- Being tested
- GnRH agonist
- Medical subject headings
- Endometriosis, Adenomyosis, Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GnRH agonistDrug
Also called Decapeptyl 3 mg
One or two intramuscular injections of Decapeptyl 3 mg
| Study group | Role | What they receive |
|---|---|---|
| Frozen embryo transfer with Hormonal Replacement Therapy (HRT) | No intervention | Patient will received usual Hormonal Replacement Therapy for a Frozen embryo transfer composed of estrogens and progestins. |
| Frozen embryo transfer with HRT and GnRH agonist | Experimental | Patient will received 1 or 2 injection of GnRH agonist priori to usual Hormonal Replacement Therapy for a Frozen embryo transfer composed of estrogens and progestins. Receives: Drug: GnRH agonist |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical pregnancy rate in both groups at last visit ultrasound
Clinical pregnancy will be defined by any cardiac activity detected during the ultrasound performed at the last visit.
Measured: 3 months after frozen embryon transfer
Secondary outcomes (3)
Successful implantation rate on the number of patients included
The implantation rate will be evaluated by the number of successful implantations out of the total number of attempts.
Measured: 3 months after frozen embryon transfer
Rates of miscarriages on the number of patients included
The miscarriage rate will be determined by the number of effective miscarriages over the number of successful implantations.
Measured: 3 months after frozen embryon transfer
Side effects related to treatment with Decapeptyl 3 mg
Collection of side effects related to treatment with Decapeptyl 3 mg
Measured: 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2020
- Study start18 Mar 2021
- Primary completion18 Jun 2026 (estimated)
- Study completion18 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hopital Foch
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paul Pirtea, Dr, Study director, Hopital Foch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04356664
- Sponsor's protocol ID
- 2019_0012
- Acronym
- DECATEC
- Status last verified
- Jan 2026
- First submitted
- 20 Apr 2020
- Last updated
- 16 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Benefit of Gonadotropin-releasing Hormone (GnRH) Agonist Before Frozen Embryo Transfer in Patients With Endometriosis and / or Adenomyosis: Randomized Prospective Study
- ClinicalTrials.gov ID
- NCT04356664
- Acronym / sponsor ID
- DECATEC / 2019_0012
- Conditions
- Endometriosis, Adenomyosis, Infertility, Female
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Hopital FochUniversity, hospital or other
- Study start
- 18 Mar 2021 (actual)
- Primary completion
- 18 Jun 2026 (estimated)
- Study completion
- 18 Jun 2026 (estimated)
- First posted
- 22 Apr 2020 (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.
Women suffering from endometriosis and/or adenomyosis may also suffer from infertility. GnRH agonist injection could improve implantation and therefore increase the pregnancy rate in these patients. This study was designed to evaluate effects of the additional of GnRH agonist (single or 2 doses) to the routine oestrogens and progestins use as support before Frozen Embryon Transfer as compared to oestrogens and progestins only.
Detailed description
Endometriosis reveals the presence of glands or endometrial stroma outside the uterus, responsible for pain and infertility. Adenomyosis illustrates an invagination of endometrial islets within the myometrium, leading to a disturbance of its contractile activity, also potentiated by local hyperestrogenism.
These two pathologies are often associated, and express an alteration of the eutopic endometrium by pro-inflammatory markers responsible for a lower implantation rate.
GnRH agonists are known to decrease these pro-inflammatory markers (cytochrome P450 and Cox 2 aromatase) in the eutopic endometrium of women with endometriosis or adenomyosis.
Patients will received 1 or 2 injection of GnRH delay agonist (Decapeptyl 3mg) approximately 1 month before the frozen embryo transfer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Frozen embryo transfer with Hormonal Replacement Therapy (HRT) | No intervention | –Patient will received usual Hormonal Replacement Therapy for a Frozen embryo transfer composed of estrogens and progestins. |
| Frozen embryo transfer with HRT and GnRH agonist | Experimental | Drug: GnRH agonistPatient will received 1 or 2 injection of GnRH agonist priori to usual Hormonal Replacement Therapy for a Frozen embryo transfer composed of estrogens and progestins. |
Who may qualify
- Ages
- 18 to 36 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Women aged 18 to 36 years (women ≥18 years to <36 years) with endometriosis and / or adenomyosis
- Having benefited from In vitro fertilisation /intracytoplasmic micro-injection with freeze all and for whom the frozen embryon transfer of a blastocyst is planned
- A normal uterine cavity
- An MRI showing endometriosis and / or adenomyosis during the inclusion visit
- Having signed a consent form
Key exclusion criteria (31 listed)
- Patient aged <18 years and ≥ 36 years
- BMI> 35
- History of implantation failures (≥ 2)
- Endometrial alterations: synechiae, polyps, myomas, hyperplasia, hematometra
- known hydrosalpinx uni or bilateral
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 |
|---|---|---|
| GnRH agonistAlso: Decapeptyl 3 mgOne or two intramuscular injections of Decapeptyl 3 mg | Drug | Frozen embryo transfer with HRT and GnRH agonist |
Primary outcome
Clinical pregnancy rate in both groups at last visit ultrasound
Time frame: 3 months after frozen embryon transfer
Clinical pregnancy will be defined by any cardiac activity detected during the ultrasound performed at the last visit.
3 secondary outcomes
Successful implantation rate on the number of patients included
Time frame: 3 months after frozen embryon transfer
Rates of miscarriages on the number of patients included
Time frame: 3 months after frozen embryon transfer
Side effects related to treatment with Decapeptyl 3 mg
Time frame: 15 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2026.
- 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.
Paul Pirtea, Dr study director
Hopital Foch
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing GnRH agonist in people with Endometriosis and Adenomyosis, run by Hopital Foch 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 6 inclusion and 31 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: looking for participants now, as of the sponsor's last update on 16 Jan 2026. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elisabeth Hulier-Ammar, Dr (0033146251175 ext. +33, e.hulier-ammar@hopital-foch.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical pregnancy rate in both groups at last visit ultrasound (time frame: 3 months after frozen embryon transfer). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Jan 2026.