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

Launched by HOPITAL FOCH · Apr 20, 2020

Keywords

ClinConnect Summary

This clinical trial is studying the potential benefits of using a medication called GnRH agonist before transferring frozen embryos in women who have endometriosis or adenomyosis, conditions that can lead to infertility. Researchers want to see if giving this medication, either as one or two injections, along with standard hormone treatments, can improve the chances of a successful pregnancy compared to just using hormone treatments alone.

To participate in this study, women aged 18 to 36 who have been diagnosed with endometriosis or adenomyosis and are planning to undergo a frozen embryo transfer may be eligible. Participants will receive either the GnRH agonist or the standard treatment and will be monitored for their pregnancy outcomes. It's important to note that certain medical conditions and previous treatments may prevent some women from joining the trial to ensure their safety. If you have questions about your eligibility or the study, it's a good idea to talk to your healthcare provider for more information.

Gender

FEMALE

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.