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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Withdrawn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

About this trial

This is an interventional treatment trial for Infertility

Eligibility Criteria

25 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

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Withdrawn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

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Primary Completion Date

August 2015 (Actual)

Study Completion Date

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3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Weill Medical College of Cornell University

4. Oversight

Data Monitoring Committee

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

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

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Utility of Fallopian Tube Cocultures in Assisted Reproductive Technology

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