Effect of hCG on Receptivity of the Human Endometrium
Condition: Infertility; Subfertility
MeSH terms: Infertility
Intervention: human chorionic gonadotropin (hCG); Placebo Comparator (for hCG)
Intervention description: 500IU of hCG diluted to a final volume of 50ul in IVF media ("Global"-trademark); 50ul of IVF medium ("Global"-trademark) to mimic hCG infusion
Intervention MeSH terms: Chorionic Gonadotropin
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 15.0
Sex: Female
Minimum age: 18 Years
Maximum age: 34 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: embryo; implantation; blastocyst; in vitro fertilization; human chorionic gonadotropin

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:

          1. between the ages of 18-34 years old

          2. 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)

          3. meet the ASRM criteria for oocyte donation

        Exclusion Criteria:

          1. younger than 18 years old or older than 34 years old

          2. 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)

          3. do not meet the ASRM criteria for oocyte donation