Endometrium Immunomodulation by in Utero Administration of Peripheral Blood Mononuclear Cells

What Was Tested

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

One of the most limiting factors in the field of assisted reproduction is implantation failure.

It had five arms (groups): IIU control group (placebo comparator), IIU PBMC group (active comparator), FIV control group (placebo comparator), FIV PBMC group (active comparator) and RIF group (active comparator).

The registry classes the interventions as procedure.

Who Took Part

423 actual participants took part.

It was open to women only aged from 18 years with no upper age limit.

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

Examples of who could join: Study participants must be over 18 years old. For the recurrent implantation failure (RIF) group only: Patients described as having RIF, i.e. having had ≥ 3 good quality embryo transfers.

The full record lists 3 inclusion and 4 exclusion criteria; among the exclusions: patients requiring a donation of gametes (eggs or spermatozoa); couples in which one or the other has a chromosomal abnormality; patients who are starting an iui cycle under ovulation testing.

How the Study Was Run

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

The endometriosis participants were allocated by chance, so the hCG (human chorionic gonadotropin) group and the comparison group should start out alike.

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

Neither the endometriosis 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 2017-03-22 with completion listed for 2020-02-01.

It ran at 1 site in Canada.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Biochemical pregnancy rate (time frame: Two weeks following embryo transfer or 3 weeks following intrauterine insemination). Clinical pregnancy rate (time frame: Six to 8 weeks of gestation).

It also tracked 3 secondary outcomes, for example Peripheral blood mononuclear cells populations distribution at Day 0, Peripheral blood mononuclear cells populations distribution at Day 2 and Cytokines expression levels.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of hCG (human chorionic gonadotropin) in 423 people with endometriosis.

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, Endometriosis research.