Effect of Intrauterine Injection of Hcg Before ET on Clinical Outcomes in IVF/ICSI Cycles

What Was Tested

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

Subfertility is the inability to conceive after 12 months of regular unprotected sexual intercourse.

As a treatment for subfertility, Assisted Reproductive Techniques (ART) have been a choice for subfertile couples.

It had two arms (groups): Intervention Group (experimental) and Control Group (no intervention).

Group that will receive intrauterine injection of human Chorionic Gonadotropin before ET.

Control Group.

The registry classes the interventions as drug.

More on the Plan

In the day of ET, number and quality of Embryos will be decided according to the routine practice guided by the local protocol.

For both groups the researchers will use Intra-Uterine Insemination (IUI) catheter (Sperm Trans, Sperm Processor) to inject the solution inside the uterine cavity 4 minutes before ET.

The researchers will standardize the procedure of ET for all women apart from the intervention versus control step.

All women participating in the study will be put in lithotomy position.

Who Took Part

Enrollment: 181 actual participants took part.

It was open to women only aged from 18 years up to 43 years.

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

Examples of who could join: Infertility, male or female factor. Women undergoing ICSI/IVF.

The full record lists 2 inclusion and 4 exclusion criteria; among the exclusions: functional azoospermia; submucous uterine myomas or previous myomectomy; hydrosalpinges without prior excision or occlusion of the tubal ostia.

How the Study Was Run

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

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 2018-07-08 with completion listed for 2020-10-04.

It ran at 1 site in Egypt.

Its stated primary purpose is prevention.

What Was Measured

The main thing measured (primary outcome): Live Birth Rate (LBR) (time frame: 9 months).

It also tracked 3 secondary outcomes, for example Clinical Pregnancy Rate (cPR), Implantation Rate (IR) and Miscarriage rate (MR).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of hCG (human chorionic gonadotropin) in 181 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.