Ignite Creation Date:
2024-05-05 @ 7:18 PM
Last Modification Date:
2024-10-26 @ 9:47 AM
Study NCT ID:
NCT00646893
Status:
SUSPENDED
Last Update Posted:
2010-02-23
First Post:
2008-03-26
Brief Title:
Preimplantation Genetic Diagnosis for the Indication of Advanced Reproductive Age
Sponsor:
Reprogenetics
Organization:
Reprogenetics
Study Overview
Official Title:
Comparison of Embryo Transfer With and Without PGS for the Indication of Advanced Reproductive Age 37-42 in Patients Undergoing ART
Status:
SUSPENDED
Status Verified Date:
2010-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
lack of appropriate funding
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The objective of this study is to demonstrate that Preimplantation Genetic diagnosis will significantly reduce spontaneous abortions and increase ongoing pregnancy rates in patients of advanced maternal age 37-42 undergoing IVF We would like to test this hypothesis by a randomized trial performed with the most suitable conditions using very successful IVF laboratories capable to perform the embryo biopsy under strict controlled conditions after proper training and validation of the techniques
Detailed Description:
Indications Patients of advanced reproductive age wishing to receive preimplantation genetic screening in ART
Objectives To demonstrate that Preimplantation Genetic diagnosis PGD will significantly reduce spontaneous abortions and increase ongoing pregnancy rates in patients of advanced maternal age 37-42 undergoing IVF
Test Method Preimplantation Genetic Screening through FISH Treatment In Vitro Fertilization treatment The resulting embryos of the test group will undergo embryo biopsy followed by PGD with FISH using a 10-probe test with no result rescue
Study Population 978 infertile women undergoing ART Major Inclusions Premenopausal infertile women wishing to conceive aged 37 42 years inclusive regular menstrual cycles and screening early follicular phase FSH within normal limits
Major Exclusions Clinically significant systemic disease any contraindication to pregnancy or carrying pregnancy to term known ASRM Grade III or IV endometriosis clinically significant abnormal findings on a transvaginal ultrasound within 6 weeks prior to the beginning of OCP treatment extrauterine pregnancy within 3 months prior to the beginning of OCP treatment poor response in a previous ART cycle 3 oocytes retrieved 3 prior initiated consecutive ART cycles without a clinical pregnancy prior severe OHSS TESA and TESE patients patients carriers of chromosomal or genetic diseases
Randomization Eligible patients will be randomized in a 11 ratio to either
Group A Hatching or Group B Hatching PGS Study Procedures The study will be conducted on an outpatient basis All pre-study screening assessments will be performed prior to treatment start
Post-treatment Oocyte retrieval and embryology procedures will be Procedures performed according to the usual practice of the study center Test Method Hatching embryo biopsy fixation and Fluorescence in-situ Hybridization FISH will be performed strictly in line with the methodology included in this protocol and only carried out by technicians certified by Reprogenetics
Primary Endpoint ongoing pregnancy rate past 2nd trimester Secondary Endpoints implantation rate pregnancy rate miscarriage rate and live birth
Objectives To demonstrate that Preimplantation Genetic diagnosis PGD will significantly reduce spontaneous abortions and increase ongoing pregnancy rates in patients of advanced maternal age 37-42 undergoing IVF
Test Method Preimplantation Genetic Screening through FISH Treatment In Vitro Fertilization treatment The resulting embryos of the test group will undergo embryo biopsy followed by PGD with FISH using a 10-probe test with no result rescue
Study Population 978 infertile women undergoing ART Major Inclusions Premenopausal infertile women wishing to conceive aged 37 42 years inclusive regular menstrual cycles and screening early follicular phase FSH within normal limits
Major Exclusions Clinically significant systemic disease any contraindication to pregnancy or carrying pregnancy to term known ASRM Grade III or IV endometriosis clinically significant abnormal findings on a transvaginal ultrasound within 6 weeks prior to the beginning of OCP treatment extrauterine pregnancy within 3 months prior to the beginning of OCP treatment poor response in a previous ART cycle 3 oocytes retrieved 3 prior initiated consecutive ART cycles without a clinical pregnancy prior severe OHSS TESA and TESE patients patients carriers of chromosomal or genetic diseases
Randomization Eligible patients will be randomized in a 11 ratio to either
Group A Hatching or Group B Hatching PGS Study Procedures The study will be conducted on an outpatient basis All pre-study screening assessments will be performed prior to treatment start
Post-treatment Oocyte retrieval and embryology procedures will be Procedures performed according to the usual practice of the study center Test Method Hatching embryo biopsy fixation and Fluorescence in-situ Hybridization FISH will be performed strictly in line with the methodology included in this protocol and only carried out by technicians certified by Reprogenetics
Primary Endpoint ongoing pregnancy rate past 2nd trimester Secondary Endpoints implantation rate pregnancy rate miscarriage rate and live birth
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