Uterine Irrigation Method in Infertility Patients Who Require PGD

NCT ID: NCT02676479

Last Updated: 2016-06-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-29
• Study Completion Date: 2016-12-31

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.

Conditions

Pre-Implantation Embryo Recovery; Genetic Diseases, Inborn

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Uterine Lavage Group

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 39 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Previvo Genetics

INDUSTRY

Sponsor Role: collaborator

Acibadem Fulya Hospital

OTHER

Sponsor Role: collaborator

Istanbul University

OTHER

Sponsor Role: lead

Responsible Party

Ercan Bastu

Associate Professor of Obstetrics and Gynecology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ercan Bastu, MD,AssocProf

Role: PRINCIPAL_INVESTIGATOR

Istanbul University School of Medicine

Locations

Istanbul University School of Medicine

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Study Documents

Document Type: Clinical Study Report

View Document

Other Identifiers

2016

Identifier Type: -

Identifier Source: org_study_id