The Effect of Granulocyte Colony Stimulating Factor Versus Human Chorionic Gonadotropin in Females With a History of RIF

What Was Tested

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

One hundred patients who suffered from recurrent implantation failure in intracytoplasmic sperm injection (ICSI) were allocated in the study.

On ovum pick-up day, 50 of them were intrauterine injected with granulocyte colony-stimulating factor (G-CSF) and the other 50 were injected with intrauterine Human Chorionic Gonadotropins (HCG).

The clinical pregnancy rate was evaluated as a primary outcome and ultrasound imaging of the gestational sac was evaluated as a secondary outcome.

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

Females With a History of Recurrent Implantation Failure in Intra Cytoplasmic Sperm Injection will receive Granulocyte Colony Stimulating Factor as a treatment.

Females With a History of Recurrent Implantation Failure in Intra Cytoplasmic Sperm Injection will receive Human Chorionic Gonadotropin as a treatment.

The registry classes the interventions as drug.

More on the Plan

One hundred patients suffering from recurrent implantation failure in intracytoplasmic sperm injection (ICSI) were included in the study.

The patients were randomly allocated into two groups.

The intervention group consisted of 50 patients who received intrauterine injected with granulocyte colony-stimulating factor (G-CSF).

The other group (the control group) consisted of 50 patients and injected with intrauterine Human Chorionic Gonadotropins (HCG).

Who Took Part

100 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

It was run as a randomized, parallel-group and open-label study.

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

Groups ran in parallel: each of the female fertility participants stayed in one arm throughout.

Being open-label, the hCG (human chorionic gonadotropin) study did not mask who received what.

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 ultrasound image of Gestational sac.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of hCG (human chorionic gonadotropin) in 100 people with female fertility.

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, Female fertility research.