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

Primary Purpose

Endometriosis, Adenomyosis, Infertility, Female

Status
Recruiting
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
GnRH agonist
Sponsored by
Hopital Foch
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endometriosis

Eligibility Criteria

18 Years - 36 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Hopital FochRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Frozen embryo transfer with Hormonal Replacement Therapy (HRT)

Frozen embryo transfer with HRT and GnRH agonist

Arm Description

Patient will received usual Hormonal Replacement Therapy for a Frozen embryo transfer composed of estrogens and progestins.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
Side effects related to treatment with Decapeptyl 3 mg
Collection of side effects related to treatment with Decapeptyl 3 mg

Full Information

First Posted
April 20, 2020
Last Updated
February 27, 2023
Sponsor
Hopital Foch
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1. Study Identification

Unique Protocol Identification Number
NCT04356664
Brief Title
Benefit of GnRH Agonist Before Frozen Embryo Transfer in Patients With Endometriosis and/or Adenomyosis
Acronym
DECATEC
Official Title
Benefit of Gonadotropin-releasing Hormone (GnRH) Agonist Before Frozen Embryo Transfer in Patients With Endometriosis and / or Adenomyosis: Randomized Prospective Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 18, 2021 (Actual)
Primary Completion Date
June 18, 2025 (Anticipated)
Study Completion Date
June 18, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hopital Foch

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometriosis, Adenomyosis, Infertility, Female

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Frozen embryo transfer with Hormonal Replacement Therapy (HRT)
Arm Type
No Intervention
Arm Description
Patient will received usual Hormonal Replacement Therapy for a Frozen embryo transfer composed of estrogens and progestins.
Arm Title
Frozen embryo transfer with HRT and GnRH agonist
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
GnRH agonist
Other Intervention Name(s)
Decapeptyl 3 mg
Intervention Description
One or two intramuscular injections of Decapeptyl 3 mg
Primary Outcome Measure Information:
Title
Clinical pregnancy rate in both groups at last visit ultrasound
Description
Clinical pregnancy will be defined by any cardiac activity detected during the ultrasound performed at the last visit.
Time Frame
3 months after frozen embryon transfer
Secondary Outcome Measure Information:
Title
Successful implantation rate on the number of patients included
Description
The implantation rate will be evaluated by the number of successful implantations out of the total number of attempts.
Time Frame
3 months after frozen embryon transfer
Title
Rates of miscarriages on the number of patients included
Description
The miscarriage rate will be determined by the number of effective miscarriages over the number of successful implantations.
Time Frame
3 months after frozen embryon transfer
Title
Side effects related to treatment with Decapeptyl 3 mg
Description
Collection of side effects related to treatment with Decapeptyl 3 mg
Time Frame
15 months

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Treatment of female infertility
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
36 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elisabeth Hulier-Ammar, Dr
Phone
0033146251175
Ext
+33
Email
e.hulier-ammar@hopital-foch.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Marc Ayoubi, Pr
Organizational Affiliation
Hopital Foch
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Paul Pirtea, Dr
Organizational Affiliation
Hopital Foch
Official's Role
Study Director
Facility Information:
Facility Name
Hopital Foch
City
Suresnes
ZIP/Postal Code
92150
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paul Pirtea
Phone
+331 46 25 35 20
Email
p.pirtea@hopital-foch.com

12. IPD Sharing Statement

Plan to Share IPD
No

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

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