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Preimplantation Genetic Diagnosis for the Indication of Advanced Reproductive Age

This study has suspended participant recruitment.
(lack of appropriate funding)
Sponsor:
Information provided by:
Reprogenetics
ClinicalTrials.gov Identifier:
NCT00646893
First received: March 26, 2008
Last updated: February 21, 2010
Last verified: February 2010
  Purpose

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.


Condition Intervention Phase
Infertility
Procedure: Preimplantation Genetic Diagnosis (PGD)
Phase 4

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Reprogenetics:

Primary Outcome Measures:
  • ongoing pregnancy rate (past 2nd trimester). [ Time Frame: after 21 days, 20 weeks, and 7 month of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 1200
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)
Arms Assigned Interventions
No Intervention: 1
Control: assisted hatching, without Preimplantation Genetic Diagnosis
Experimental: 2
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)
Other Names:
  • PGS
  • Preimplantation Genetic Screening

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 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.

  Eligibility

Ages Eligible for Study:   37 Years to 42 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Premenopausal infertile women wishing to conceive
  • Aged 37 42 years, inclusive,
  • Regular menstrual cycles (generally 25 35 days in length) and screening early follicular phase FSH within normal limits.

Exclusion Criteria:

  • 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;
  • ≥ 3 prior, initiated, consecutive ART cycles without a clinical pregnancy;
  • Prior severe OHSS;
  • TESA and TESE patients;
  • Patients carriers of chromosomal or genetic diseases.
  • Egg donation cycles.
  • Frozen Cycles.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00646893

Locations
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
Reprogenetics
Livingston, New Jersey, United States, 07039
Spain
IVI Barcelona
Barcelona, Spain
Sponsors and Collaborators
Reprogenetics
Investigators
Principal Investigator: Santiago Munne, PhD Reprogenetics
  More Information

Publications:
Responsible Party: Santiago Munne, Reprogenetics
ClinicalTrials.gov Identifier: NCT00646893     History of Changes
Other Study ID Numbers: Reprogenetics-01
Study First Received: March 26, 2008
Last Updated: February 21, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Reprogenetics:
aneuploidy
miscarriage
pregnancy loss
PGD
PGS
Preimplantation Genetic Diagnosis
chromosome abnormalities
IVF
ART

Additional relevant MeSH terms:
Infertility
Genital Diseases, Female
Genital Diseases, Male

ClinicalTrials.gov processed this record on November 27, 2014