Utility of Fallopian Tube Cocultures in Assisted Reproductive Technology
Primary Purpose
Infertility
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Laparoscopic Surgery (Biopsies of fallopian tube lumen) using a laparoscopic brush/biopsy device
Sponsored by
About this trial
This is an interventional treatment trial for Infertility
Eligibility Criteria
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
Exclusion Criteria:
- Pregnancy
- Undiagnosed vaginal bleeding
- Fallopian tube disease
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Fallopian Tube Co-culture
Arm Description
fallopian tube biopsy for co-culture of embryos
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Number of participants with Adverse Events as a measure of Safety and Tolerability
We will assess the incidence of pain, bleeding and infection rates
Full Information
NCT ID
NCT02341339
First Posted
October 27, 2014
Last Updated
August 10, 2015
Sponsor
Weill Medical College of Cornell University
1. Study Identification
Unique Protocol Identification Number
NCT02341339
Brief Title
Utility of Fallopian Tube Cocultures in Assisted Reproductive Technology
Official Title
Utility of Fallopian Tube Cocultures in Assisted Reproductive Technology
Study Type
Interventional
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Withdrawn
Study Start Date
undefined (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Weill Medical College of Cornell University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fallopian Tube Co-culture
Arm Type
Experimental
Arm Description
fallopian tube biopsy for co-culture of embryos
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic Surgery (Biopsies of fallopian tube lumen) using a laparoscopic brush/biopsy device
Primary Outcome Measure Information:
Title
Number of participants with good embryo quality as a measure of efficacy
Description
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
Secondary Outcome Measure Information:
Title
Number of participants with Adverse Events as a measure of Safety and Tolerability
Description
We will assess the incidence of pain, bleeding and infection rates
Time Frame
8 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Exclusion Criteria:
Pregnancy
Undiagnosed vaginal bleeding
Fallopian tube disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rony Elias, MD
Organizational Affiliation
Weill Medical College of Cornell University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Utility of Fallopian Tube Cocultures in Assisted Reproductive Technology
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