BAP-EB as a Predictive Tool for Endometrial Receptivity and Pregnancy Outcome of IVF Treatment
Condition: Subfertility
MeSH terms: Infertility
Study type: Interventional

Summary: 
      To determine the predictive value of attachment rate of human embryonic stem cells
      (hESC)-derived trophoblast spheroids (BAP-EB, embryo surrogate) onto endometrial epithelial
      cells (EEC) on success of IVF treatment and to use the model to identify EEC surface
      biomarkers for endometrial receptivity.
    

Detailed description: 
      Study Objectives and Purpose:

      There are three objectives in this study:

        1. To determine the predictive value of the attachment rate of BAP-EB onto EEC on success
           of IVF treatment. The attachment rate of BAP-EB onto EEC of subfertile women in a
           natural cycle preceding the IVF cycle will be determined and correlated with the
           cumulative live birth rate in a subsequent stimulated IVF cycle and the derived
           frozen-thawed embryo transfer (FET) cycles.

        2. To identify the surface molecules on EEC responsible for attaching to BAP-EB. The
           biotin-labeled primary EEC surface proteins that bind onto BAP-EB will be purified and
           identified by mass spectrometry. The bound proteins from "receptive" and "non-receptive"
           endometrial cell lines will be compared. The expression of the surface proteins on
           endometrial samples obtained in Objective 1will be correlated with their BAP-EB
           attachment rate.

        3. To compare the BAP-EB attachment rate and expression of the attachment-related
           "receptive" EEC surface molecules between pre-receptive and receptive endometrium and
           between women with repeated implantation failure (RIF) and subfertile women due to male
           factors. To identify women with endometrial defects, women with RIF and failed IVF after
           preimplantation genetic screening (PGS) will be recruited. The latter recruitment
           criterion excludes RIF due to embryo aneuploidy.

      Subjects:

      Patients will be recruited from the Centre of Assisted Reproduction and Embryology, the
      University of Hong Kong at Queen Mary Hospital (HKU-QMH CARE) and at University of Hong
      Kong-Shenzhen Hospital (HKU-SZH CARE), the Dr Stephen Chow Chun-kay Assisted Reproduction
      Centre, Kwong Wah Hospital (SCCARC).

      Treatment of Subjects:

      Endometrial biopsies will be collected from the subjects and the attachment rate of BAP-EB
      onto isolated EEC will be associated with the implantation and pregnancy outcomes in IVF and
      the expressions of the isolated surface proteins.

      Study duration: 36 months

      Assessment of Safety:

        1. Specification of safety parameters. Abdominal pain after endometrial aspirate

        2. The methods and timing for assessing, recording, and analysing safety parameters.
           Subjects will be asked to contact investigators if they notice abdominal pain after
           endometrial aspirate

        3. Procedures for eliciting reports of and for recording and reporting adverse event and
           intercurrent illnesses. Any abdominal pain will be documented in subjects' medical notes
           and they will be asked for any adverse effects and intercurrent illness when receiving
           IVF treatment.

        4. The type and duration of the follow-up of subjects after adverse events. Subjects will
           be followed up in the Department of Obstetrics and Gynaecology as long as they have the
           adverse events.
    

Intervention name(s): endometrial biopsy
Intervention type(s): Procedure
Intervention description(s): An endometrial biopsy taken 2-3 months prior to IVF cycle
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Subfertility; In-vitro fertilization; BAP-EB; Endometrial epithelial cells; Repeated implantation failure