Effect of hCG on Receptivity of the Human Endometrium

What Was Tested

The trial (phase 4) is built around hCG (human chorionic gonadotropin) for endometriosis.

Worldwide, 1 in 12 couples experience difficulty in getting pregnant and seek the help of assisted reproductive technologies (ART) such as in vitro fertilization (IVF-egg is fertilized by sperm outside the body), ovarian stimulation (medications are used to stimulate egg development) and intra-cytoplasmic injection (ICSI-single sperm is injected directly into the egg).

Regardless of the ART procedure being performed, the newly fertilized embryo must still implant into the mothers endometrium (inner lining of uterus).

It had two arms (groups): Drug: human chorionic gonadotropin (hCG) (experimental) and IVF media ("Global"-trademark) (placebo comparator).

Placebo Comparator for hCG. A single intrauterine infusion of IVF media without hCG will be administered to participants in the control group three days after oocyte retrieval. Two days after this infusion, participant will return to clinic and a sample of uterine secretory proteins and endometrial tissue, will be obtained via uterine lavage and endometrial biopsy, respectively, for research analysis.

The registry classes the interventions as drug.

More on the Plan

Embryo implantation in humans is surprisingly inefficient and represents a major limiting factor for enhancement of ART success rates (ref 1-2).

Successful implantation requires synchronized development between the newly fertilized embryo and the maternal endometrium within a specific window of time.

In mammals, this coordinated development is accomplished, in part, by embryonic secretions which alert the body that fertilization has occurred.

One of the earliest proteins produced by the embryo is human chorionic gonadotropin (hCG).

Who Took Part

15 actual participants took part.

It was open to women only aged from 18 years up to 34 years.

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

Examples of who could join: Between the ages of 18-34 years old. Successfully applied for oocyte donor status at the Investigators Infertility clinic (The Fertility Center, 3230 Eagle Park Drive NE, suite 100. Grand Rapids MI 49525). Meet the ASRM criteria for oocyte donation.

The full record lists 3 inclusion and 3 exclusion criteria; among the exclusions: younger than 18 years old or older than 34 years old; do not meet the asrm criteria for oocyte donation.

How the Study Was Run

Design: non-randomized, parallel-group and open-label.

The hCG (human chorionic gonadotropin) group and the comparison group ran side by side rather than switching.

Being open-label, the hCG (human chorionic gonadotropin) study did not mask who received what.

It started in 2013-01 with completion listed for 2016-03.

It ran at 1 site in United States.

Its stated primary purpose is basic science.

What Was Measured

The main thing measured (primary outcome): Expression of hCG Target NOTCH1 Protein by IHC in Endometrial Glands (time frame: 2 days following infusion of hCG or IVF media). Expression of hCG Target NOTCH1 Protein by IHC in Endometrial Stroma (time frame: 2 days following infusion of hCG or IVF media). Expression of hCG Target C3 Protein by IHC in Endometrial Stroma (time frame: 2 days following infusion of hCG or IVF media).

What This Means in Plain Language

Put simply, this is a phase 4, non-randomized trial of hCG (human chorionic gonadotropin) in 15 people with endometriosis.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the hCG (human chorionic gonadotropin) compound page, Endometriosis research.