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

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Brief Title

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

Official Title

Benefit of Gonadotropin-releasing Hormone (GnRH) Agonist Before Frozen Embryo Transfer in Patients With Endometriosis and / or Adenomyosis: Randomized Prospective Study

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.

Study Phase

Phase 2/Phase 3

Study Type

Interventional

Primary Outcome

Clinical pregnancy rate in both groups at last visit ultrasound

Secondary Outcome

 Successful implantation rate on the number of patients included

Condition

Endometriosis

Intervention

GnRH agonist

Study Arms / Comparison Groups

 Frozen embryo transfer with Hormonal Replacement Therapy (HRT)
Description:  Patient will received usual Hormonal Replacement Therapy for a Frozen embryo transfer composed of estrogens and progestins.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Drug

Estimated Enrollment

180

Start Date

March 30, 2021

Completion Date

January 1, 2022

Primary Completion Date

January 1, 2022

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.

Gender

Female

Ages

18 Years - 36 Years

Accepts Healthy Volunteers

No

Contacts

Jean-Marc Ayoubi, Pr, 0033146251175, [email protected]

Administrative Informations

NCT ID

NCT04356664

Organization ID

2019_0012

Responsible Party

Sponsor

Study Sponsor

Hopital Foch

Study Sponsor

Jean-Marc Ayoubi, Pr, Principal Investigator, Hopital Foch

Verification Date

March 2021