Benefit of GnRH Agonist Before Frozen Embryo Transfer in Patients With Endometriosis and/or Adenomyosis (DECATEC)

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.

Study Overview

• Status: Recruiting
• Conditions: Endometriosis; Adenomyosis; Infertility, Female
• Intervention / Treatment: Drug: GnRH agonist

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 Type: Interventional
• Enrollment (Estimated): 180
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Elisabeth Hulier-Ammar, Dr; Phone Number: +33 0033146251175; Email: e.hulier-ammar@hopital-foch.com

Study Locations

• France
  • Suresnes, France, 92150
    • Recruiting
    • Hôpital Foch
    • Contact: Paul Pirtea; Phone Number: +331 46 25 35 20; Email: p.pirtea@hopital-foch.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 36 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Frozen embryo transfer with Hormonal Replacement Therapy (HRT); Patient will received usual Hormonal Replacement Therapy for a Frozen embryo transfer composed of estrogens and progestins.
Experimental: Frozen embryo transfer with HRT and GnRH agonist; 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.	Drug: GnRH agonist; One or two intramuscular injections of Decapeptyl 3 mg; Other Names: Decapeptyl 3 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 months after frozen embryon transfer

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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	15 months

Collaborators and Investigators

• Sponsor: Hopital Foch
• Investigators: Study Director: Paul Pirtea, Dr, Hôpital Foch

Study record dates

Study Major Dates

• Study Start (Actual): March 18, 2021
• Primary Completion (Estimated): June 18, 2026
• Study Completion (Estimated): June 18, 2026

Study Registration Dates

• First Submitted: April 20, 2020
• First Submitted That Met QC Criteria: April 20, 2020
• First Posted (Actual): April 22, 2020

Study Record Updates

• Last Update Posted (Estimated): January 16, 2026
• Last Update Submitted That Met QC Criteria: January 15, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Uterine Diseases; Genital Diseases, Female; Infertility; Adenomyosis; Infertility, Female; Endometriosis; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins; Triptorelin Pamoate; Gonadotropin-Releasing Hormone
• Other Study ID Numbers: 2019_0012

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
• product manufactured in and exported from the U.S.: No