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Benefit of GnRH Agonist Before Frozen Embryo Transfer in Patients With Endometriosis and/or Adenomyosis
Plain-language guide to NCT04356664: phase 2, phase 3 randomized trial of Triptorelin, endometriosis, 180 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT04356664
- Phase
- phase 2, phase 3
- Status
- recruiting participants
- Start
- 2021-03-18
- Completion (planned or actual)
- 2026-06-18
- Participants
- 180 (estimated)
- Design
- randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Endometriosis; Adenomyosis; Infertility, Female
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
The trial (phase 2, phase 3) is built around Triptorelin for endometriosis.
Women suffering from endometriosis and/or adenomyosis may also suffer from infertility.
It had two arms (groups): Frozen embryo transfer with Hormonal Replacement Therapy (HRT) (no intervention) and Frozen embryo transfer with HRT and GnRH agonist (experimental).
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.
The registry classes the interventions as drug.
More on the Plan
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.
Who Took Part
The registry lists 180 planned participants were the target.
It was open to women only aged from 18 years up to 36 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Women aged 18 to 36 years (women ≥18 years to \<36 years) with endometriosis and / or adenomyosis. 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.
The full record lists 6 inclusion and 31 exclusion criteria; among the exclusions: patient aged \<18 years and ≥ 36 years; BMI\> 35; history of implantation failures (≥ 2).
How the Study Was Run
Design: randomized, parallel-group and open-label.
The endometriosis participants were allocated by chance, so the Triptorelin group and the comparison group should start out alike.
Groups ran in parallel: each of the endometriosis participants stayed in one arm throughout.
Being open-label, the Triptorelin study did not mask who received what.
It started in 2021-03-18 with completion listed for 2026-06-18.
It ran at 1 site in France.
Its stated primary purpose is treatment.
What Was Measured
Researchers chose this as the main measure: Clinical pregnancy rate in both groups at last visit ultrasound (time frame: 3 months after frozen embryon transfer).
It also tracked 3 secondary outcomes, for example Successful implantation rate on the number of patients included and Rates of miscarriages on the number of patients included.
What This Means in Plain Language
Put simply, this is a phase 2, phase 3, randomized trial of Triptorelin in 180 people with endometriosis.
It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Triptorelin compound page, Endometriosis research.
Our Notes on the Compound
Triptorelin: A 10-amino-acid GnRH analog (Trelstar, Decapeptyl, Triptodur) used in prostate cancer, early puberty and fertility protocols.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.