Human Chorionic Gonadotropin Versus Granulocyte Colony Stimulating Factor in Increasing Pregnancy Rate in ICSI

Plain-language guide to NCT04606082: not phased randomized trial of hCG (human chorionic gonadotropin), 200 participants. Who took part, design and what was measured.

Key Facts

Registry ID: NCT04606082
Phase: not phased
Status: status unknown
Start: 2020-10-30
Completion (planned or actual): 2021-01-10
Participants: 200 (estimated)
Design: randomized, open label (everyone knows who gets what), treatment
Conditions studied: Fertility Disorders
Results posted: not yet

What This Study Did, in Plain Language

What Was Tested

This registered not phased trial tested hCG (human chorionic gonadotropin).

It had two arms (groups): Group 1 (experimental) and Group 2 (active comparator).

Granulocyte Colony Stimulated Factor was intrauterine injected once at ovum pick up day.

The registry classes the interventions as drug.

More on the Plan

The clinical pregnancy rate was evaluated as a primary outcome after 14 days and ultrasound imaging of gestational sac was evaluated as a secondary outcome after 6 weeks.

Who Took Part

Enrollment: 200 planned participants were the target.

It was open to women only aged from 30 years up to 50 years.

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

Examples of who could join: Females suffering from recurrent implantation failure and undergoing ICSI.

The full record lists 1 inclusion and 1 exclusion criteria; among the exclusions: presence of comorbidity as diabetes, hypertension, heart diseases, or endocrine disorders.

How the Study Was Run

Design: randomized, parallel-group and open-label.

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.

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

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 2020-10-30 with completion listed for 2021-01-10.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: clinical pregnancy rate (time frame: after 14 days from positive pregnancy test).

It also tracked 1 secondary outcome, for example Gestational sac imaging.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of hCG (human chorionic gonadotropin) in 200 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.

hCG (human chorionic gonadotropin) 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.