Uterine Irrigation Method in Infertility Patients Who Require PGD

NCT02676479 | Unknown

• 1 other identifier: 2016
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Pre-Implantation Embryo Recovery; Genetic Diseases, Inborn

Outcome Measures

Primary Outcomes (1)

• Blastocyst Retrieval

  Number of blastocyst retrieved

  3 months

Secondary Outcomes (1)

• Blastocyst Quality

  3 months

Study Arms (1)

Uterine Lavage Group

EXPERIMENTAL

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

Interventions

Uterine Lavage Group 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.

Uterine Lavage Group

Eligibility Criteria

• Age: 21 Years - 39 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul University: lead
• Previvo Genetics: collaborator
• Acibadem Fulya Hospital: collaborator

Study Sites (1)

Istanbul University School of Medicine

Istanbul, 34093, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Genetic Diseases, Inborn

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Ercan Bastu, MD,AssocProf

  Istanbul University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Obstetrics and Gynecology

Study Record Dates

• First Submitted: January 23, 2016
• First Posted: February 8, 2016
• Study Start: February 1, 2016
• Primary Completion: September 1, 2016
• Study Completion: December 1, 2016
• Last Updated: June 1, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)