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Effect of GnRH Antagonist vs Agonist Long on IVF Outcome, Peak Estradiol Level,and Duration of Stimulation
Plain-language guide to NCT01669291: not phased randomized trial of HMG (Human Menopausal Gonadotropin) and Cetrorelix, 43 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT01669291
- Phase
- not phased
- Status
- completed
- Start
- 2012-07
- Completion (planned or actual)
- 2014-05
- Participants
- 43 (actual)
- Design
- randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Fertility
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
The trial (not phased) is built around HMG (Human Menopausal Gonadotropin) and Cetrorelix.
The purpose of this study is to determine if utilizing GnRH antagonists versus agonist long protocol during controlled ovarian stimulation (COH) with human-derived gonadotropins for assisted reproduction affects IVF outcome, peak estradiol level, and duration of stimulation.
It had two arms (groups): Bravelle & Menopur Agonist Long Protocol (active comparator) and Bravelle & Menopur Antagonist Protocol (active comparator).
The registry classes the interventions as drug.
Who Took Part
The registry lists 43 actual participants took part.
It was open to women only aged from 21 years up to 40 years.
Healthy volunteers could join, not only people with the condition.
Examples of who could join: Ages 21-40 (inclusive up to 41). Day 2-4 FSH \< or equal to 10. Antimullerian Hormone (AMH) greater than or equal to 1.0. Between 5 and 20 antral follicles on day 2-4. Body Mass Index (BMI)\>or equal to 18 and \< or equal to 32.
The full record lists 5 inclusion and 4 exclusion criteria; among the exclusions: polycystic ovarian disease; endometriosis greater than stage i; testicular aspirated sperm.
How the Study Was Run
Design: randomized, single-group and open-label.
Random assignment meant chance, not the researchers, decided who got HMG (Human Menopausal Gonadotropin) and who got the comparison, which limits bias.
Nothing was hidden in this open-label HMG (Human Menopausal Gonadotropin) study: the participants and staff both knew the treatment.
Everyone received the same intervention, so there was no separate comparison group inside the trial.
It started in 2012-07 with completion listed for 2014-05.
It ran at 1 site in United States.
Its stated primary purpose is treatment.
What Was Measured
It also tracked 2 secondary outcomes, for example To determined if COH in IVF patients using Bravelle & Menopur with antagonists results in lower peak estradiol levels compared to agonist.
What This Means in Plain Language
Put simply, this is a not phased, randomized trial of HMG (Human Menopausal Gonadotropin) and Cetrorelix in 43 people.
The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the HMG (Human Menopausal Gonadotropin) compound page and the Cetrorelix compound page, all human trials.
Our Notes on the Compounds
HMG (Human Menopausal Gonadotropin): Menotropins: a glycoprotein preparation that supplies follicle-stimulating hormone (FSH) and luteinizing hormone (LH) activity.
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.