Utility of Fallopian Tube Cocultures in Assisted Reproductive Technology

NCT02341339 | Withdrawn

• 1 other identifier: WeillMC
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Infertility

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Number of participants with Adverse Events as a measure of Safety and Tolerability

  8 weeks

Study Arms (1)

Fallopian Tube Co-culture

EXPERIMENTAL

fallopian tube biopsy for co-culture of embryos

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

Interventions

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

Fallopian Tube Co-culture

Eligibility Criteria

• Age: 25 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Pregnancy
• Undiagnosed vaginal bleeding
• Fallopian tube disease

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead

MeSH Terms

Conditions

Infertility

Interventions

Laparoscopy

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Rony Elias, MD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2014
• First Posted: January 19, 2015
• Primary Completion: August 1, 2015
• Last Updated: August 11, 2015

Record last verified: 2015-08