Preimplantation Genetic Diagnosis for the Indication of Advanced Reproductive Age
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Screening
|Official Title:||Comparison of Embryo Transfer With and Without PGS for the Indication of Advanced Reproductive Age (37-42) in Patients Undergoing ART|
- ongoing pregnancy rate (past 2nd trimester). [ Time Frame: after 21 days, 20 weeks, and 7 month of treatment ] [ Designated as safety issue: No ]
- spontaneous abortions [ Time Frame: within 1st and 2nd trimester ] [ Designated as safety issue: No ]
- pregnancy [ Time Frame: one month for presence of fetal sac ] [ Designated as safety issue: No ]
- implantation [ Time Frame: first month, for presence of fetal sacs ] [ Designated as safety issue: No ]
|Study Start Date:||June 2008|
|Estimated Study Completion Date:||April 2011|
|Estimated Primary Completion Date:||January 2011 (Final data collection date for primary outcome measure)|
No Intervention: 1
Control: assisted hatching, without Preimplantation Genetic Diagnosis
Test: embryo biopsy with Preimplantation Genetic Diagnosis
Procedure: Preimplantation Genetic Diagnosis (PGD)
one-cell embryo biopsy on day 3 of development. The cell will be analyzed by FISH using probes for X,Y,13,15,16,17,18,21,22 chromosomes. Cells with dubious results will be reanalyzed by "no result rescue" (Colls et al. 2007)
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 1:1 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00646893
|United States, California|
|ART Reproductive Center,|
|Beverly Hills, California, United States, 90210|
|United States, Illinois|
|Fertility Centers of Illinois|
|Highland Park, Illinois, United States, 60035|
|United States, New Jersey|
|Institute for Reproductive Medicine and Science at Saint Barnabas Medical Center|
|Livingston, New Jersey, United States, 07039|
|Livingston, New Jersey, United States, 07039|
|Principal Investigator:||Santiago Munne, PhD||Reprogenetics|