Uterine Irrigation Method in Infertility Patients Who Require PGD

Genetic Diseases, Inborn Clinical Trial

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.

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02676479
• Other study ID #: 2016
• Status: Enrolling by invitation
• Phase: N/A
• First received: January 23, 2016
• Last updated: May 27, 2016
• Start date: February 2016
• Est. completion date: December 2016

Study information

• Verified date: May 2016
• Source: Istanbul University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 30
• Est. completion date: December 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years to 39 Years

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Genetic Diseases, Inborn
• Infertility
• Pre-Implantation Embryo Recovery

Intervention

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.

Locations

Country	Name	City	State
Turkey	Istanbul University School of Medicine	Istanbul

Sponsors (3)

Lead Sponsor	Collaborator
Istanbul University	Acibadem Fulya Hospital, Previvo Genetics

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blastocyst Retrieval	Number of blastocyst retrieved	3 months	No
Secondary	Blastocyst Quality	Number of cells developed in each blastocyst	3 months	No