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Dual Trigger Versus GnRHa Trigger Combined With Luteal HCG Administration
Plain-language guide to NCT02330770: phase 4 randomized trial of hCG (human chorionic gonadotropin), 225 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT02330770
- Phase
- phase 4
- Status
- status unknown
- Start
- 2016-06-06
- Completion (planned or actual)
- 2024-12-31
- Participants
- 225 (estimated)
- Design
- randomized, open label (everyone knows who gets what), supportive_care
- Conditions studied
- Infertility
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
In this phase 4 trial, researchers set out to test hCG (human chorionic gonadotropin).
It had three arms (groups): Dual trigger group (active comparator), one (active comparator) and one (active comparator).
The registry classes the interventions as drug.
More on the Plan
The GnRH antagonist fixed protocol will be used for controlled ovarian hyperstimulation (COH).
Transvaginal sonography (TVS) scan will be performed regularly for monitoring of the follicular growth (folliculometry).
Who Took Part
The registry lists 225 planned participants were the target.
It was open to women only aged from 20 years up to 35 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Women subjected to ICSI through controlled ovarian hyperstimulation (COH) with pituitary downregulation by GnRH antagonist.
The full record lists 2 inclusion and 7 exclusion criteria; among the exclusions: age \< 20 years or \> 35 years; BMI \< 19 kg/m2 or \> 35 kg/m2; moderate or severe endometriosis.
How the Study Was Run
It was run as a randomized, parallel-group and open-label study.
Because people in this hCG (human chorionic gonadotropin) 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 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 2016-06-06 with completion listed for 2024-12-31.
It ran at 2 sites in Egypt (2).
Its stated primary purpose is supportive care.
What Was Measured
Researchers chose this as the main measure: Clinical pregnancy rate (time frame: 6 weeks after embryo transfer).
It also tracked 4 secondary outcomes, for example Oocyte maturation rate, Incidence of early OHSS, Implantation rate and Miscarriage rate.
What This Means in Plain Language
Put simply, this is a phase 4, randomized trial of hCG (human chorionic gonadotropin) in 225 people.
Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the hCG (human chorionic gonadotropin) compound page, all human trials.
Our Notes on the Compound
hCG (human chorionic gonadotropin): An LH analog that drives Leydig-cell testosterone production.
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.