Effects of Intrauterine Flushing With Human Chorionic Gonadotropin on ICSI Outcome

What Was Tested

This registered phase 4 trial tested hCG (human chorionic gonadotropin).

A number of infertile women who were prepared for ICSI and immediately post ova pick up intrauterine flushing with human chorionic gonadotropin was done to study the effect of this drug on ICSI outcome and ultrasound parameter.

It had three arms (groups): Group A (active comparator), Group B (active comparator) and group C (no intervention).

Patient not receive any treatement.

The registry classes the interventions as drug.

More on the Plan

Written informed consent was obtained before being included in the study.

Three groups of patients according to type of intervention.

Assessment of plasma hormone level was done for all.

The quantification of serum TNF and IL-10 levels was conducted through the application of the enzyme-linked immunosorbent assay (ELISA) methodology at a privately-owned laboratory.

Who Took Part

Enrollment: 90 actual participants took part.

It was open to women only aged from 18 years up to 40 years.

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

Examples of who could join: The patient\'s consent to participate in the research study is crucial for data collection and analysis. Each pair of individuals undergoing IVF/ICSI procedures typically possess grade 1 (G1) embryos during the embryo transfer process. The age range of the female participants varied from 18 to 40 years. Infertility arising from female factors, including issues like blocked fallopian tubes, lack of ovulation, and unexplained fertility challenges, was examined. Male-related factors contributing to infertility were also taken into consideration.

The full record lists 6 inclusion and 0 exclusion criteria.

How the Study Was Run

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

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

Neither the participants nor the staff measuring them knew who was on hCG (human chorionic gonadotropin), so expectations could not easily colour the readings.

Those kept unaware of assignments: participant and care provider.

It started in 2022-10-23 with completion listed for 2024-01-23.

It ran at 1 site in Iraq.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Serum Level of TNF-alfa,IL-10, for All Participants in Three Study Group at Day of Ova Pickup Compared to That at Day of Embryo Transfer. Ultrasound Parameter (RI,PI) (time frame: Within 10 minutes after ova pickup, ten minute before embryo transfer using ultrasound device). Systole Flow/ Diastole Flow (time frame: within ten minute post ova pickup and ten minute prior to embryo transfer which is done within 3-5 days post ova pickup).

It also tracked 1 secondary outcome, for example Intra Cytoplasmic Sperm Injection Outcome.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of hCG (human chorionic gonadotropin) in 90 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the hCG (human chorionic gonadotropin) compound page, all human trials.