Prospective Feasibility Study: Fallopian tube cells will be obtained from patients undergoing laparoscopic surgery during their surgical evaluation of infertility. Of note, these patients are already scheduled to undergo surgery as part of their standard of care.
The surgical technique will involve laparoscopic brush and tissue biopsies of the fallopian tube lumen. A small piece of the fallopian tube lining will be removed during the surgery.The biopsy is a minimally invasive and relatively pain free procedure. Co culture blood serum will be drawn at least one day prior to the biopsy and during the IVF cycle. The fallopian tube sample is sent to the Center for Reproductive Medicine (CRM) lab where it is treated, purified and frozen. The next month or whenever the physician deems appropriate, the patient will then undergo a typical IVF cycle and will be given standard medication protocol determined by her physician to stimulate egg growth in her ovaries. The patient's eggs will be retrieved and mixed with sperm. At this time, the lab will begin to thaw and grow the fallopian tube cells. Once fertilization is confirmed, the patient's embryos will be placed on top of her own (now thawed) fallopian tube cells and allowed to grow. Subsequently, the embryos will be placed on top of her uterus for implantation and pregnancy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Number of participants with good embryo quality as a measure of efficacy
The outcomes measures for embryo quality will include an assessment of the embryo grade, embryo fragmentation rates, implantation rates and pregnancy rates.
Time frame: 8 weeks
Number of participants with Adverse Events as a measure of Safety and Tolerability
We will assess the incidence of pain, bleeding and infection rates
Time frame: 8 weeks
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