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Effect of GnRH Agonist vs GnRH Antagonist on Oocyte Morphology During IVF/ICSI
Plain-language guide to NCT04724486: phase 4 non-randomized trial of hCG (human chorionic gonadotropin) and HMG (Human Menopausal Gonadotropin), 50 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT04724486
- Phase
- phase 4
- Status
- completed
- Start
- 2020-08-22
- Completion (planned or actual)
- 2022-03-15
- Participants
- 50 (actual)
- Design
- non-randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- In Vitro Fertilization; Intracytoplasmic Sperm Injection; Infertility
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
The trial (phase 4) is built around hCG (human chorionic gonadotropin) and HMG (Human Menopausal Gonadotropin).
Selection of developmentally competent oocytes enhances IVF efficiency.
Usually, oocyte quality is determined based on its nuclear maturation and the presence of specific cytoplasmic and extracytoplasmic morphologic features.
It had two arms (groups): Agonist Group (Long protocol): (active comparator) and Antagonist Group (Flexible protocol): (experimental).
The registry classes the interventions as drug.
Who Took Part
50 actual participants took part.
It was open to women only aged from 18 years up to 39 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Women undergoing IVF/ICSI. Age: 18-39 years. Both ovaries present.
The full record lists 3 inclusion and 8 exclusion criteria; among the exclusions: age ≥ 40 years; history of three or more previous ivf failures; patients with hormonal disorders like hyperprolactinemia, thyroid disorders.
How the Study Was Run
Design: non-randomized, parallel-group and open-label.
Groups ran in parallel: each of the participants stayed in one arm throughout.
Nothing was hidden in this open-label hCG (human chorionic gonadotropin) study: the participants and staff both knew the treatment.
It started in 2020-08-22 with completion listed for 2022-03-15.
It ran at 1 site in Syria.
Its stated primary purpose is treatment.
What Was Measured
It also tracked 12 secondary outcomes, for example Number of oocytes retrieved:, Number of Metaphase II Oocytes (MII):, Number of Metaphase I Oocytes (MI):, Number of Germinal Vesicle Oocytes (GV):, Number of Atretic Oocytes: and Maturation Rate%:.
What This Means in Plain Language
Put simply, this is a phase 4, non-randomized trial of hCG (human chorionic gonadotropin) and HMG (Human Menopausal Gonadotropin) in 50 people.
The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the hCG (human chorionic gonadotropin) compound page and the HMG (Human Menopausal Gonadotropin) compound page, all human trials.
Our Notes on the Compounds
hCG (human chorionic gonadotropin): An LH analog that drives Leydig-cell testosterone production.
HMG (Human Menopausal Gonadotropin): Menotropins: a glycoprotein preparation that supplies follicle-stimulating hormone (FSH) and luteinizing hormone (LH) activity.
Triptorelin: A 10-amino-acid GnRH analog (Trelstar, Decapeptyl, Triptodur) used in prostate cancer, early puberty and fertility protocols.
Related Pages
- hCG (human chorionic gonadotropin) in the library
- HMG (Human Menopausal Gonadotropin) in the library
- Triptorelin in the library
- Cetrorelix in the library
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.