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Use of Degarelix in Controlled Ovarian Hyperstimulation (COH) Protocol for Women With PoliCystic Ovarian Syndrome (PCOS)
Plain-language guide to NCT01709942: phase 3 randomized trial of Cetrorelix and Degarelix, pcos, 80 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT01709942
- Phase
- phase 3
- Status
- completed
- Start
- 2012-11
- Completion (planned or actual)
- 2015-12
- Participants
- 80 (actual)
- Design
- randomized, single-blind, treatment
- Conditions studied
- PCOS; OHSS; INFERTILITY
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
This registered phase 3 trial tested Cetrorelix and Degarelix for pcos.
It had two arms (groups): degarelix group (experimental) and one (active comparator).
Group of patients treated with long acting GnRH antagonist.
Patients treated with gonadotropin and Cetrorelix ina flexible GnRH antagonist protocol.
The registry classes the interventions as drug.
More on the Plan
Women with PCOS are at risk to develop OHSS when stimulated with gonadotrophins for IVF.
The use of long acting GnRH antagonist promotes a deep suppression of LH and consequently the activity of theca cells, which secrete androgens (the precursors of estradiol), and consequently the levels of estradiol remains low.
Who Took Part
80 actual participants took part.
It was open to women only aged from 20 years up to 38 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Women with PCOS.
The full record lists 3 inclusion and 3 exclusion criteria; among the exclusions: more than 38 years old; body mass index pore than 30; other systemic diseases.
How the Study Was Run
Design: randomized, parallel-group and single-blind.
Because people in this Cetrorelix study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.
Groups ran in parallel: each of the pcos participants stayed in one arm throughout.
In this single-blind Cetrorelix study one party knew the assignments and the other did not.
Those kept unaware of assignments: participant.
It started in 2012-11 with completion listed for 2015-12.
It ran at 1 site in Italy.
Its stated primary purpose is treatment.
What Was Measured
Researchers chose this as the main measure: PREGNANCY RATE (time frame: 6 MONTHS). ovarian hyperstimulation syndrome rate (time frame: 6 MONTHS).
It also tracked 1 secondary outcome, for example implantation rate.
What This Means in Plain Language
Put simply, this is a phase 3, randomized trial of Cetrorelix and Degarelix in 80 people with pcos.
The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Cetrorelix compound page and the Degarelix compound page, PCOS research.
Our Notes on the Compounds
Cetrorelix: An FDA-approved GnRH antagonist used in IVF to prevent a premature LH surge.
Degarelix: A GnRH antagonist injection (Firmagon) for advanced prostate cancer that lowers testosterone within days without the initial surge seen with agonists.
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.