Benefit of treatment with a GnRH agonist (neurohormone) prior to frozen embryo transfer in patients with endometriosis (endometrial disease) and / or adenomyosis (another form of endometriosis)

Benefit of the GnRH agonist before frozen embryo transfer in patients with endometriosis and / or adenomyosis: randomized prospective study - DECATEC

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-003645-16-FR

Enrollment

180

Registered

2019-10-18

Start date

2020-02-25

Completion date

Unknown

Last updated

2024-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Frozen embryo transfer in patients with endometriosis and/or adenomyosis

Interventions

Trade Name: DECAPEPTYL L.P. 3mg Pharmaceutical Form: Powder and solvent for suspension for injection

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Women aged 18 to 36 years (women =18 years to =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Patient aged 35 - History of implantation failures (= 2) - Endometrial alterations: synechiae, polyps, myomas, hyperplasia, hematometry - known hydrosalpinx uni or bilateral - MRI showing no endometriosis or adenomyosis - Hypersensitivity to GnRH, GnRH analogues, or any of the excipients of DECAPEPTYL® L.P. 3 mg (see section 6.1 of the SPC in Appendix 2) - 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 - Porphyria - GnRH Agonist DECAPEPTYL® L.P. administered within 6 months prior to transfer - To be deprived of liberty or under guardianship -Pregnancy and breast feeding.

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess the impact of long-acting GnRH agonist administration on clinical pregnancy rate;Secondary Objective: To evaluate the impact of long-acting GnRH agonist administration on: - implantation rate - miscarriage rate. To measure the side effects inherent to the administration of GnRH agonist;Primary end point(s): The primary endpoint is the clinical pregnancy rate (with cardiac activity) assessed in both groups at last visit ultrasound;Timepoint(s) of evaluation of this end point: At study end.	—

Measure

Time frame

Main Objective: To assess the impact of long-acting GnRH agonist administration on clinical pregnancy rate;Secondary Objective: To evaluate the impact of long-acting GnRH agonist administration on: - implantation rate - miscarriage rate. To measure the side effects inherent to the administration of GnRH agonist;Primary end point(s): The primary endpoint is the clinical pregnancy rate (with cardiac activity) assessed in both groups at last visit ultrasound;Timepoint(s) of evaluation of this end point: At study end.

—

Secondary

Measure	Time frame
Secondary end point(s): - Successful implantation rate on the number of patients included - Rates of miscarriages on the number of patients included - Side effects related to treatment with DECAPEPTYL ® LP, 3 mg (IM);Timepoint(s) of evaluation of this end point: At study end.	—

Countries

France

Contacts

Public ContactDRCI

Hopital Foch

drci-promotion@hopital-foch.com+330146251175

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026