Uterine Irrigation Method in Infertility Patients Who Require PGD

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.

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.

Study Overview

• Status: Unknown
• Conditions: Genetic Diseases, Inborn; Pre-Implantation Embryo Recovery
• Intervention / Treatment: Device: Uterine Lavage Group

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.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey, 34093
    • Istanbul University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 39 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Uterine Lavage Group; 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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blastocyst Retrieval	Number of blastocyst retrieved	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blastocyst Quality	Number of cells developed in each blastocyst	3 months

Collaborators and Investigators

• Sponsor: Istanbul University
• Collaborators: Previvo Genetics; Acibadem Fulya Hospital
• Investigators: Principal Investigator: Ercan Bastu, MD,AssocProf, Istanbul University School of Medicine

Study record dates

Study Major Dates

• Study Start: February 1, 2016
• Primary Completion (Anticipated): September 1, 2016
• Study Completion (Anticipated): December 1, 2016

Study Registration Dates

• First Submitted: January 23, 2016
• First Submitted That Met QC Criteria: February 4, 2016
• First Posted (Estimate): February 8, 2016

Study Record Updates

• Last Update Posted (Estimate): June 1, 2016
• Last Update Submitted That Met QC Criteria: May 27, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infertility; Genetic Diseases, Inborn
• Other Study ID Numbers: 2016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Study Data/Documents

1. Clinical Study Report

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No