Utility of Fallopian Tube Cocultures in Assisted Reproductive Technology

Not Applicable

Withdrawn

• Conditions: Infertility
• Interventions: Procedure: Laparoscopic Surgery (Biopsies of fallopian tube lumen) using a laparoscopic brush/biopsy device

• Registration Number: NCT02341339
• Lead Sponsor: Weill Medical College of Cornell University

Brief Summary

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.

Detailed Description

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.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2014-10-27
• Study First Submitted QC: 2015-01-13
• Study First Posted: 2015-01-19
• Status Verified: 2015-08
• Primary Completion: 2015-08
• Last Update Submitted: 2015-08-10
• Last Update Posted: 2015-08-11

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

• Women undergoing assisted reproductive technology at Weill Cornell Medical College (WCMC) and are scheduled to undergo surgery as part of their standard of care
• Women who had a prior failed IVF cycle
• Women with normal Hysterosalpingogram (HSG) or a prior laparoscopy confirming normal tubal status
• Both the patient (potential subject) and her partner must sign the consent form

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Exclusion Criteria

• Pregnancy
• Undiagnosed vaginal bleeding
• Fallopian tube disease

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Fallopian Tube Co-culture	Laparoscopic Surgery (Biopsies of fallopian tube lumen) using a laparoscopic brush/biopsy device	fallopian tube biopsy for co-culture of embryos

Primary Outcome Measures

Name	Time	Method
Number of participants with good embryo quality as a measure of efficacy	8 weeks	The outcomes measures for embryo quality will include an assessment of the embryo grade, embryo fragmentation rates, implantation rates and pregnancy rates.

Secondary Outcome Measures

Name	Time	Method
Number of participants with Adverse Events as a measure of Safety and Tolerability	8 weeks	We will assess the incidence of pain, bleeding and infection rates