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Uterine Irrigation Method in Infertility Patients Who Require PGD

Primary Purpose

Pre-Implantation Embryo Recovery, Genetic Diseases, Inborn

Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Uterine Lavage Group
Sponsored by
Istanbul University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Pre-Implantation Embryo Recovery

Eligibility Criteria

21 Years - 39 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Premenopausal Female Age 21-39 years old.
  • BMI between 18-35 kg/m2
  • Presence of a normal uterine cavity, both fallopian tubes and their respective ovaries as assessed by hysterosalpingogram and/or sonohysterogram (SHG).
  • Regular menstrual cycles every 26-32 days
  • Male partner aged 21-40 yrs with a normal semen analysis.
  • Infertile couples, which carry hereditary genetic diseases and genetic anomalies, and have a high probability of passing these on to their children.

Exclusion Criteria:

  • Any active, uncontrolled, clinically significant medical condition as determined by the treating principal investigator
  • Previous history of prior appendectomy and/or lower abdominal surgery
  • Previous history of prior tubal surgery or ectopic pregnancy
  • Contraindication for the use of oral contraceptive pills
  • Clinically significant abnormal basic metabolic panel lab results
  • Positive test or history of any of the following conditions:
  • Human immunodeficiency virus (HIV)
  • Hepatitis B infection
  • Hepatitis C infection
  • Syphilis (RPR)
  • Chlamydial pelvic infection
  • Gonorrheal pelvic infection.
  • Positive Pregnancy Test
  • No prior IUD for 60 days and not currently in place

Sites / Locations

  • Istanbul University School of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Uterine Lavage Group

Arm Description

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 (Previvo Uterine Lavage System™, CA, U.S.A.) to recover preimplantation embryos.

Outcomes

Primary Outcome Measures

Blastocyst Retrieval
Number of blastocyst retrieved

Secondary Outcome Measures

Blastocyst Quality
Number of cells developed in each blastocyst

Full Information

First Posted
January 23, 2016
Last Updated
May 27, 2016
Sponsor
Istanbul University
Collaborators
Previvo Genetics, Acibadem Fulya Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02676479
Brief Title
Uterine Irrigation Method in Infertility Patients Who Require PGD
Official Title
The Histological and Genetic Investigation of Cells, Fluid and Tissue in the Uterine Cavity, Using the Uterine Irrigation Method, in Patients Who Suffer From Unexplained Infertility and Hereditary Genetic Disease, and Who Require PGD Scans.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Unknown status
Study Start Date
February 2016 (undefined)
Primary Completion Date
September 2016 (Anticipated)
Study Completion Date
December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University
Collaborators
Previvo Genetics, Acibadem Fulya Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed Description
The study is a prospective, single center, single-arm study to evaluate healthy cells which do not carry illnesses, by collecting and performing the histological and genetic analyses of blastocysts, endometrial tissue and cells, which have been formed in the uterus, without any burden of the morbidity and mortality caused by the oocyte collection process, and which thereby have not been subjected to any iatrogenic intervention, with uterine lavage. 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. Following lavage, a GnRH antagonist will be administered to cause lysis of multiple corpora lutea to mitigate risk of hyperstimulation from the use of fertility medication and reduce the risk of ectopic pregnancy should the lavage procedure not recover all preimplantation embryos. Recovered preimplantation embryos may be screened for aneuploidy and genetic disease, then cryopreserved for potential future use by the subjects and the Investigator separate from the purpose of this study. Each subject participates in the trial for up to 10-20 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pre-Implantation Embryo Recovery, Genetic Diseases, Inborn

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Uterine Lavage Group
Arm Type
Experimental
Arm Description
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 (Previvo Uterine Lavage System™, CA, U.S.A.) to recover preimplantation embryos.
Intervention Type
Device
Intervention Name(s)
Uterine Lavage Group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Blastocyst Retrieval
Description
Number of blastocyst retrieved
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Blastocyst Quality
Description
Number of cells developed in each blastocyst
Time Frame
3 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
39 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Premenopausal Female Age 21-39 years old. BMI between 18-35 kg/m2 Presence of a normal uterine cavity, both fallopian tubes and their respective ovaries as assessed by hysterosalpingogram and/or sonohysterogram (SHG). Regular menstrual cycles every 26-32 days Male partner aged 21-40 yrs with a normal semen analysis. Infertile couples, which carry hereditary genetic diseases and genetic anomalies, and have a high probability of passing these on to their children. Exclusion Criteria: Any active, uncontrolled, clinically significant medical condition as determined by the treating principal investigator Previous history of prior appendectomy and/or lower abdominal surgery Previous history of prior tubal surgery or ectopic pregnancy Contraindication for the use of oral contraceptive pills Clinically significant abnormal basic metabolic panel lab results Positive test or history of any of the following conditions: Human immunodeficiency virus (HIV) Hepatitis B infection Hepatitis C infection Syphilis (RPR) Chlamydial pelvic infection Gonorrheal pelvic infection. Positive Pregnancy Test No prior IUD for 60 days and not currently in place
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ercan Bastu, MD,AssocProf
Organizational Affiliation
Istanbul University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Istanbul University School of Medicine
City
Istanbul
ZIP/Postal Code
34093
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Available IPD and Supporting Information:
Available IPD/Information Type
Clinical Study Report
Available IPD/Information URL
http://www.ncbi.nlm.nih.gov/pubmed/4037016

Learn more about this trial

Uterine Irrigation Method in Infertility Patients Who Require PGD

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