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Long Acting FSH Plus Antagonist Versus Daily FSH Plus Antagonist Versus Short Agonist Protocol in Poor Responders Undergoing IVF
Plain-language guide to NCT02070198: phase 4 randomized trial of Triptorelin, 120 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT02070198
- Phase
- phase 4
- Status
- status unknown
- Start
- 2013-12
- Completion (planned or actual)
- 2014-11
- Participants
- 120 (estimated)
- Design
- randomized, single-blind, treatment
- Conditions studied
- Female Infertility; Poor Responder
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
The trial (phase 4) is built around Triptorelin.
Despite the progression in assisted reproductive technology (ART), poor ovarian response to controlled ovarian stimulation remains a challenge for clinicians and a source of distress for patients.
Multiple strategies have been tried to overcome these obstacles.
It had three arms (groups): Long acting FSH and GnrH antagonist (experimental), daily FSH and GnRH antagonist (experimental) and Triptorelin and recombinant FSH (experimental).
The registry classes the interventions as drug.
Who Took Part
Enrollment: 120 planned participants were the target.
It was open to women only aged from 25 years up to 44 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
The full record lists 1 inclusion and 6 exclusion criteria; among the exclusions: body mass index \> 30; biochemical and ultrasound evidence of polycystic ovary syndrome; stage iii-iv endometriosis.
How the Study Was Run
Design: randomized, parallel-group and single-blind.
Random assignment meant chance, not the researchers, decided who got Triptorelin and who got the comparison, which limits bias.
The Triptorelin group and the comparison group ran side by side rather than switching.
Only one side, usually the participants, was kept unaware of whether Triptorelin was given.
Those kept unaware of assignments: participant.
It started in 2013-12 with completion listed for 2014-11.
It ran at 1 site in Italy.
Its stated primary purpose is treatment.
What Was Measured
Primary outcome: Clinical pregnancy rate (time frame: Time Frame: until 12th gestational week).
It also tracked 1 secondary outcome, for example Implantation rate.
What This Means in Plain Language
Put simply, this is a phase 4, randomized trial of Triptorelin in 120 people.
Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Triptorelin compound page, all human trials.
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.