Ignite Creation Date:
2024-05-06 @ 8:07 AM
Last Modification Date:
2024-10-26 @ 11:56 AM
Study NCT ID:
NCT02676479
Status:
UNKNOWN
Last Update Posted:
2016-06-01
First Post:
2016-01-23
Brief Title:
Uterine Irrigation Method in Infertility Patients Who Require PGD
Sponsor:
Istanbul University
Organization:
Istanbul University
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2016-05
Last Known Status:
ENROLLING_BY_INVITATION
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The study will involve up to 30 pairs of male and female sexually intimate partners who are carriers for a genetic disease eg 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 partners 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 eg 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 partners 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
The study will involve up to 30 pairs of male and female sexually intimate partners who are carriers for a genetic disease eg 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 partners 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None