Phase 4
N=15
Effect of hCG on Receptivity of the Human Endometrium
Infertility · Subfertility
Bottom Line
View on ClinicalTrials.gov: NCT01786252 ↗Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Nov 2016
Primary outcome: Primary: Endometrial Staging in hCG Versus Vehicle Treated Patients — 4.0; 4.6; 3.9; 6.5 days — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- human chorionic gonadotropin (hCG) (Drug); Placebo Comparator (for hCG) (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Michigan State University
- Primary completion
- Mar 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Endometrial Staging in hCG Versus Vehicle Treated Patients |
4.0; 4.6; 3.9; 6.5 | <0.05 sig |
| PRIMARY Expression of hCG Target NOTCH1 Protein by IHC in Endometrial Glands |
111.9; 84.59 | <0.05 sig |
| PRIMARY Expression of hCG Target NOTCH1 Protein by IHC in Endometrial Stroma |
85.66; 59.8 | <0.05 sig |
| PRIMARY Expression of hCG Target C3 Protein by IHC in Endometrial Stroma |
85.3; 59.8 | <0.05 sig |
Summary
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). This implantation process in humans is surprisingly inefficient and accounts for up to 50% of ART failures. Intrauterine infusion of hCG prior to embryo transfer has recently been shown to increase pregnancy rates but the cellular mechanism for this increase is unknown.
Successful implantation requires the newly fertilized embryo and the endometrium develop in a synchronized manner. This coordinated development is accomplished, in part, by proteins secreted by the embryo which circulate throughout the maternal bloodstream and alert the maternal body organs (i.e. ovary, endometrium, breast, ect) that fertilization has occurred.
One of the earliest of these secreted proteins is human chorionic gonadotropin (hCG), which is the molecule detected in over-the-counter pregnancy tests. From previous studies, we know that hCG production by the embryo alerts the ovary to continue producing progesterone, a hormone required for pregnancy. However, very little is known about the direct effect of hCG on the endometrium during early pregnancy in humans.
Using animal models, hCG has been shown to induce specific changes in the endometrium, suggesting that embryo-derived hCG may be "priming" the endometrium in anticipation of implantation. The goal of this research study is to examine the direct effect of hCG on the human endometrium and see if this "priming effect" is also present in humans. Findings from this research may reveal whether pre-treatment with hCG can enhance ART outcomes, especially pregnancy rates.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- younger than 18 years old or older than 34 years old
- have not 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)
- do not meet the ASRM criteria for oocyte donation
Data sourced from ClinicalTrials.gov (NCT01786252). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.