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GnRH Agonist Versus hCG Trigger in Ovulation Induction With Intrauterine Insemination.

Plain-language guide to NCT03825445: not phased randomized trial of hCG (human chorionic gonadotropin), 197 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT03825445
Phase
not phased
Status
completed
Start
2016-04-01
Completion (planned or actual)
2017-06-30
Participants
197 (actual)
Design
randomized, double-blind, treatment
Conditions studied
Ovulation Induction
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

The trial (not phased) is built around hCG (human chorionic gonadotropin).

This study aims to compare clinical pregnancy rates (CPR) in patients who are administered either Gonadotropin-releasing hormone agonists (GnRHa) or human chorionic gonadotropin (hCG) for ovulation trigger in intrauterine insemination (IUI) cycles.

Total of 197 infertile women were randomly assigned to receive either GnRHa trigger (n=98 cycles) or hCG trigger (n= 99 cycles) for ovulation trigger.

It had two arms (groups): GnRHa trigger (experimental) and hCG trigger (experimental).

The registry classes the interventions as drug.

More on the Plan

Study population A total of 217 women were recruited into the sample at the first stage.

Inclusion criteria were women with bilateral tubal patency, at least one follicle ≥ 18mm in diameter on the day of trigger, and men with more than five millions total motile sperm after preparation.

Patients were randomly assigned to receive either GnRHa trigger (n=98 cycles) or hCG trigger (n= 99 cycles) for ovulation trigger.

Intervention All patients included in the study were subjected to complete history and physical.

Who Took Part

The registry lists 197 actual participants took part.

It was open to women only aged from 18 years up to 45 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Infertile women who were indicated for IUI cycles. Bilateral tubal patency. At least one follicle ≥ 18mm in diameter on the day of trigger, and. Men with more than five millions total motile sperm after preparation.

The full record lists 5 inclusion and 2 exclusion criteria; among the exclusions: no mature follicle; disagree to be enrolled.

How the Study Was Run

It was run as a randomized, parallel-group and double-blind study.

The participants were allocated by chance, so the hCG (human chorionic gonadotropin) group and the comparison group should start out alike.

The hCG (human chorionic gonadotropin) group and the comparison group ran side by side rather than switching.

Blinding on both sides kept the participants and researchers unaware of who received hCG (human chorionic gonadotropin).

Those kept unaware of assignments: participant and investigator.

It started in 2016-04-01 with completion listed for 2017-06-30.

Its stated primary purpose is treatment.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of hCG (human chorionic gonadotropin) in 197 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, 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.