Benefit of GnRH Agonist Before Frozen Embryo Transfer in Patients With Endometriosis and/or Adenomyosis
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexFemale
Age18-36
SponsorHopital Foch
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Patient aged <18 years and ≥ 36 years
BMI> 35
History of implantation failures (≥ 2)
Endometrial alterations: synechiae, polyps, myomas, hyperplasia, hematometra
Trial design
Design model
Parallel
Treatments tested in this trial
GnRH agonist
DrugOne or two intramuscular injections of Decapeptyl 3 mg
Treatment groups
180 Participants
are divided into 2 treatment groupsGroup A: Frozen embryo transfer with Hormonal Replacement Therapy (HRT)No intervention 0 interventions
Group B: Frozen embryo transfer with HRT and GnRH agonistExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
3 months after frozen embryon transferSecondary outcomes
1
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.
Time frame
3 months after frozen embryon transfer2
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.
Time frame
3 months after frozen embryon transfer3
Side effects related to treatment with Decapeptyl 3 mg
Collection of side effects related to treatment with Decapeptyl 3 mg
Time frame
15 monthsSponsors and contacts
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Source ClinicalTrials.gov