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Uterine Irrigation Method in Infertility Patients Who Require PGD

NCT02676479 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2016-06-01

No results posted yet for this study

Summary

The study will involve up to 30 pairs of male and female sexually intimate partners who are carriers for a genetic disease (e.g Sickle Cell Disease or Thalassemia) and at high risk of transmitting the gene. The female partner will be superovulated to mature multiple oocytes which can be fertilized, inseminated with her partner's sperm through intra-uterine insemination (IUI). Four to six days after IUI, the female partner will undergo a non-surgical uterine lavage procedure to recover preimplantation embryos.

Conditions

  • Pre-Implantation Embryo Recovery
  • Genetic Diseases, Inborn

Interventions

DEVICE

Uterine Lavage Group

The PI places the Lavage Catheter per instructions for use * Use of a tenaculum or cervical stitch is required * Use of saline to wash the cervix is required * Use of abdominal ultrasound guidance with a full bladder is required The PI records if there was clinically significant fluid loss through the cervix.

Sponsors & Collaborators

  • Previvo Genetics

    collaborator INDUSTRY

  • Acibadem Fulya Hospital

    collaborator OTHER

  • Istanbul University

    lead OTHER

Principal Investigators

  • Ercan Bastu, MD,AssocProf · Istanbul University School of Medicine

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Max Age
39 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-29
Primary Completion
2016-09-30
Completion
2016-12-31

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02676479 on ClinicalTrials.gov