Effect of GnRH Agonist vs GnRH Antagonist on IVF/ICSI Outcomes in Polycystic Ovary Syndrome Patients.

Plain-language guide to NCT04727671: 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: NCT04727671
Phase: phase 4
Status: completed
Start: 2019-12-22
Completion (planned or actual): 2021-08-15
Participants: 50 (actual)
Design: non-randomized, open label (everyone knows who gets what), treatment
Conditions studied: In Vitro Fertilization; Intracytoplasmic Sperm Injection; Infertility; Polycystic Ovary Syndrome
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).

This prospective, non-randomised, open-label, clinical trial is conducting on polycystic ovary syndrome (PCOS) subjects to compare the effects of two pituitary suppression regimens; GnRH Agonist-Long Protocol and GnRH Antagonist-Flexible Protocol on clinical and embryological IVF/ICSI outcomes, and on the follicular fluid levels of Placental Growth Factor (PlGF); which is known for his pivotal role in the regulation of ovulation, embryo development, and implantation.

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: PCOS women diagnosed according to the Rotterdam criteria undergoing IVF/ICSI. Age: 18-39 years. Both ovaries present.

The full record lists 3 inclusion and 7 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.

Everyone knew when hCG (human chorionic gonadotropin) was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2019-12-22 with completion listed for 2021-08-15.

It ran at 1 site in Syria.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Follicular fluid Placental Growth Factor (PlGF) Concentrations: (time frame: Immediately after oocyte retrieval (35±2 hours after hCG administration)).

It also tracked 9 secondary outcomes, for example Number of oocytes retrieved, Number of Metaphase II Oocytes (MII):, Maturation Rate%:, Fertilization Rate%:, Cleavage Rate%: and Embryo Quality:.

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.

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.