Effect of Intrauterine Injection of HCG on Clinical Pregnancy Outcome in Repeated Implantation Failure Patients

What Was Tested

The trial (not phased) is built around hCG (human chorionic gonadotropin).

It had two arms (groups): HCG group (experimental) and control group (placebo comparator).

The registry classes the interventions as drug and other.

Who Took Part

Enrollment: 47 actual participants took part.

It was open to women only aged from 18 years up to 36 years.

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

Examples of who could join: Repeated implantation failure patients: ≥ 3 times IVF-embryo transfer failed to help pregnancy (biochemical or non-pregnant). Age ≤36 years old. Normal histopathological stage (+5-7). 0 endometrial CD138 positive cell. Natural cycle frozen embryo transfer.

The full record lists 7 inclusion and 6 exclusion criteria; among the exclusions: scar uterus (diverticulum or incision false lumen after cesarean section); intrauterine adhesions; untreated hydrosalpinx.

How the Study Was Run

Design: randomized, parallel-group and triple-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, investigator and outcomes assessor.

It started in 2018-12-10 with completion listed for 2019-08-18.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: clinical pregnancy rate (time frame: 28 days after blastocyst transfer).

It also tracked 4 secondary outcomes, for example clinical implantation rate, ongoing pregnancy rate, ectopic pregnancy rate and abortion rate.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of hCG (human chorionic gonadotropin) in 47 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.