Intrauterine Injection of Human Chorionic Gonadotrophin and Pregnancy Rate in ICSI

What Was Tested

In this not phased trial, researchers set out to test hCG (human chorionic gonadotropin).

The process of implantation is a locally controlled paracrine/juxtacrine-mediated phenomenon.

It had two arms (groups): Human chorionic gonadotrophin (experimental) and control (no intervention).

The Control Group included 50 patients who went through the ICSI conventional protocol without intrauterine injection.

The registry classes the interventions as drug.

More on the Plan

The endometrium can only support implantation during a discrete period of about 6 to 9 days after LH peak; termed the "window of implantation".

During this period endometrial glandular epithelium is differentiated into a highly secretory state with the production of various cytokines and growth factors that facilitate implantation.

In fact, several substances secreted from the embryo or the endometrium affect implantation.

These include cyclic adenosine monophosphate, relaxin, gonadotropin, prostaglandin E2, and glycoprotein hormones.

Who Took Part

The registry lists 100 actual participants took part.

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.

How the Study Was Run

The set-up was randomized, parallel-group and single-blind.

Random assignment meant chance, not the researchers, decided who got hCG (human chorionic gonadotropin) and who got the comparison, which limits bias.

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

In this single-blind hCG (human chorionic gonadotropin) study one party knew the assignments and the other did not.

Those kept unaware of assignments: investigator.

It started in 2018-02-20 with completion listed for 2018-06-01.

It ran at 1 site in Egypt.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): implantation rate (time frame: six weeks from the last menstrual period).

It also tracked 2 secondary outcomes, for example biochemical pregnancy and clinical pregnancy.

What This Means in Plain Language

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