Utility of Fallopian Tube Cocultures in Assisted Reproductive Technology

Infertility Clinical Trial

Official title:

Utility of Fallopian Tube Cocultures in Assisted Reproductive Technology

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02341339
• Other study ID #: WeillMC
• Status: Withdrawn
• Phase: N/A
• First received: October 27, 2014
• Last updated: August 10, 2015

Study information

• Verified date: August 2015
• Source: Weill Medical College of Cornell University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years to 40 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infertility

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	8 weeks	No
Secondary	Number of participants with Adverse Events as a measure of Safety and Tolerability	We will assess the incidence of pain, bleeding and infection rates	8 weeks	Yes