Intrauterine Injection of Human Chorionic Gonadotropin Injection (hCG) Before Embryo Transfer on Pregnancy Outcomes in Frozen Embryo Transfer Cycles.

What Was Tested

This registered phase 3 trial tested hCG (human chorionic gonadotropin).

The present study is designed as a pilot study with 50 patients in each group.

Data collection form will be filled by the researcher who does not know the type of intervention in each group.

It had three arms (groups): experimental group (experimental), placebo group (placebo comparator) and control group (other).

The patients who receive only 40 μL of tissue culture medium (G.2plus ref. 10132, Vitrolife) is injected intrauterine, approximately 7 minutes before embryo transfer.

The patients for whom the embryonic transfer is done without the intrauterine hCG injection. The ET procedure is performed just like in the other two groups.

The registry classes the interventions as drug and procedure.

More on the Plan

This randomized double blinded clinical trial is conducted to evaluate the effect of intrauterine injection of human chorionic gonadotropin (hCG) before frozen embryo transfer (ET).

The study is performed according to the Declaration of Helsinki for medical research.

All participants provide informed consent after explaining the purpose of the study.

All the patients with primary infertility who have only one fresh implantation failure and undergoing frozen embryo transfer cycles are enrolled.

Who Took Part

The registry lists 180 actual participants took part.

It was open to women only aged from 19 years up to 39 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Patients with history of one fresh embryo transfer failure. Patients with Primary infertility. Patients with at least one embryo with excellent quality.

The full record lists 3 inclusion and 9 exclusion criteria; among the exclusions: female age over 40 years old; severe male factor (azoospermia); endometriosis diagnosis and the presence of hydrosalpinges.

How the Study Was Run

The set-up was randomized, parallel-group and double-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.

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 2015-01 with completion listed for 2018-12.

It ran at 1 site in Iran.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Implantation rate (time frame: 6 weeks).

It also tracked 3 secondary outcomes, for example Pregnancy loss, Early miscarriage rate and Late miscarriage rate.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of hCG (human chorionic gonadotropin) in 180 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.