Endometrial Receptivity Profile in Patients With Endometrial Proliferation Defects
Condition: Endometrial Dysfunction
Study type: Observational

Summary: 
      The purpose of this study is to determine the differences that exist in RNA molecules, the
      biochemical process of methylation, and estrogen receptor binding in patients that have
      failed to produce adequate endometrium in synthetic embryo transfer cycles when compared to
      patients whose endometrium thickness is within normal limits.
    

Detailed description: 
      The purpose of this study is to determine the differences that may exist in RNA molecules,
      the biochemical process of methylation, and estrogen receptor binding (this is a group of
      proteins in the cell that are activated by the hormone estrogen) in patients that have failed
      to produce adequate endometrium (uterine lining) in synthetic embryo transfer cycles when
      compared to patients whose endometrium thickness is within normal limits.

      Appropriate embryo development and luteal phase (when fertilization and implantation occur)
      transformation of the endometrium create a small window of opportunity where successful
      implantation can occur. The interaction between the embryo and the endometrium is complex and
      poorly understood.

      The endometrium, which consists of two layers called the functionalis and basalis, goes
      through changes during the menstrual cycle. The changes that occur are needed for successful
      implantation of an embryo. The proliferative phase of the menstrual cycle is primarily
      governed by estrogen and is responsible for the thickening of the endometrium. Progesterone
      primarily controls the last half of the menstrual cycle and causes changes which allows for
      embryo implantation.

      Through in vitro fertilization (IVF), the investigators have seen that the correct thickness
      of endometrium is a marker of successful implantation and ongoing pregnancy, although the
      reason for this is not entirely clear. In order to better understand the processes that may
      occur in the endometrium, the investigators are conducting a study which evaluates
      biochemical markers of those patients who have shown a failure to proliferate during previous
      synthetic IVF frozen cycles and biochemical markers of control patients who have no known
      endometrial pathology.
    

Intervention name(s): Estradiol Valerate, Progesterone in Oil, Leuprolide
Intervention type(s): Other
Intervention description(s): Patients will undergo a Leuprolide endometrial preparatory cycle using estradiol valerate, progesterone in oil and once completed will have a uterine aspiration and biopsy performed.
Intervention MeSH terms: Leuprolide; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol; Polyestradiol phosphate; Progesterone
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients who have undergone a synthetic endometrial proliferation cycle in preparation for
        an embryo transfer that were identified as having a proliferative phase defect will serve
        as the subjects. Normal, healthy patients who are undergoing infertility treatment for
        single gene disorder, family balancing, or male factor infertility will serve as controls.
        The study will occur as part of a cryosynthetic preparatory cycle prior to embryo transfer.
        There will be 10 cases and 10 controls recruited for participation in the study.
      
Biospecimen description: 
      One tube of serum (approximately 3.5 mL) will be collected from participant at each visit via
      venipuncture. An uterine aspiration and endometrial biopsy sample will be taken at Day 6 of
      Progestrone Adminstration.
    
Keywords: Endometrial Insufficiency; Endometrial Receptivity