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New treatment option for Endometriosis
Official title Benefit of GnRH Agonist Before Frozen Embryo Transfer in Patients With Endometriosis and/or Adenomyosis
ClinicalTrials.gov ID: NCT04356664
What this study is testing
What is GnRH agonist?
GnRH agonist is an investigational medicine, given as an injection into a muscle, being studied as a potential treatment for endometriosis.
Also referred to as Decapeptyl 3 mg.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 36, women only
You may be able to join if
- 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...
- A normal uterine cavity
- An MRI showing endometriosis and / or adenomyosis during the inclusion visit
- Having signed a consent form
You likely can't join if
- 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
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Suresnes, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 36 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Suresnes, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.