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Ovarian Stimulation Using Recombinant Follicle-stimulating Hormone (FSH) and Gonadotrophin Releasing Hormone (GnRH) Agonist in Alternate Days
Plain-language guide to NCT01468441: not phased randomized trial of Triptorelin and Cetrorelix, 96 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT01468441
- Phase
- not phased
- Status
- completed
- Start
- 2011-09
- Completion (planned or actual)
- 2012-03
- Participants
- 96 (actual)
- Design
- randomized, single-blind, treatment
- Conditions studied
- Infertility
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
The trial (not phased) is built around Triptorelin and Cetrorelix.
It had two arms (groups): GnRH agonist (experimental) and GnRH antagonist (active comparator).
Administration of GnRH agonist in alternate days, recombinant FSH and hCG microdose for ovarian stimulation.
Daily administration of GnRH antagonist, recombinant FSH and hCG microdose for ovarian stimulation.
The registry classes the interventions as drug.
More on the Plan
No patient had received any hormone therapy for at least 60 days preceding the study.
Eligible patients who agreed to participate were randomized in two treatment groups.
Patients were allocated to a GnRH analogue treatment group according to a computer-generated randomization table.
Who Took Part
Enrollment: 96 actual participants took part.
It was open to women only aged up to 35 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Women of good physical and mental health. Under 37 years old, with regular menstrual cycles of 25-35 days. Normal basal FSH and LH levels. BMI less than 30 kg/m2. Presence of both ovaries and intact uterus.
The full record lists 9 inclusion and 0 exclusion criteria.
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 2011-09 with completion listed for 2012-03.
It ran at 1 site in Brazil.
Its stated primary purpose is treatment.
What Was Measured
Primary outcome: cost of treatment (time frame: One month).
It also tracked 1 secondary outcome, for example Implantation and pregnancy rates.
What This Means in Plain Language
Put simply, this is a not phased, randomized trial of Triptorelin and Cetrorelix in 96 people.
The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Triptorelin compound page and the Cetrorelix compound page, all human trials.
Our Notes on the Compounds
Triptorelin: A 10-amino-acid GnRH analog (Trelstar, Decapeptyl, Triptodur) used in prostate cancer, early puberty and fertility protocols.
Cetrorelix: An FDA-approved GnRH antagonist used in IVF to prevent a premature LH surge.
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.