Intramuscular Injection of Human Chorionic Gonadotropin in Frozen Embryo Transfer Cycles

What Was Tested

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

This study is a randomized controlled clinical trial to compare the pregnancy outcomes of infertile women with frozen embryo transfer.

It had two arms (groups): The group of frozen embryo transfer with intramuscular injection of human chorionic gonadotropin. (experimental) and The group of frozen embryo transfer without intramuscular injection of human chorionic gonadotropin. (no intervention).

In this group, endometrial preparation for embryo transfer will be through the standard protocol using a gonadotropin-releasing hormone agonist. Embryo transfer will be done without human chorionic gonadotropin intramuscular injection.

The registry classes the interventions as drug.

More on the Plan

During implantation, the biochemical crosstalk between the endometrium and embryo has a very important role.

The endometrium secrets cytokines and growth factors that modulate embryonic differentiation and early development.

One of the important molecular messages between the embryo and endometrium is human chorionic gonadotropin (HCG).

Block randomization method is designed by epidemiologist using STATA software version 13 and the number of blocks considered is 6.

Who Took Part

Enrollment: 200 actual participants took part.

It was open to women only aged from 20 years up to 40 years.

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

Examples of who could join: Infertile women candidates for frozen embryo transfer. Age 20-40 years. Body Mass Index under than 30 Kg/m2. Having at least three good quality embryos.

The full record lists 4 inclusion and 11 exclusion criteria; among the exclusions: women with hematologic and autoimmune disorders; couples with chromosomal and genetic abnormalities; women with uterine anomalies.

How the Study Was Run

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

Nothing was hidden in this open-label hCG (human chorionic gonadotropin) study: the participants and staff both knew the treatment.

It started in 2020-07-01 with completion listed for 2022-08-22.

It ran at 1 site in Iran.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Rate of Implantation (time frame: 6 weeks after embryo transfer).

What This Means in Plain Language

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