Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Preimplantation Genetic Diagnosis for the Indication of Advanced Reproductive Age

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00646893
Recruitment Status : Suspended (lack of appropriate funding)
First Posted : March 31, 2008
Last Update Posted : February 23, 2010
Sponsor:
Information provided by:
Reprogenetics

Tracking Information
First Submitted Date  ICMJE March 26, 2008
First Posted Date  ICMJE March 31, 2008
Last Update Posted Date February 23, 2010
Study Start Date  ICMJE June 2008
Estimated Primary Completion Date January 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 28, 2008)
ongoing pregnancy rate (past 2nd trimester). [ Time Frame: after 21 days, 20 weeks, and 7 month of treatment ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 28, 2008)
  • spontaneous abortions [ Time Frame: within 1st and 2nd trimester ]
  • pregnancy [ Time Frame: one month for presence of fetal sac ]
  • implantation [ Time Frame: first month, for presence of fetal sacs ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Preimplantation Genetic Diagnosis for the Indication of Advanced Reproductive Age
Official Title  ICMJE Comparison of Embryo Transfer With and Without PGS for the Indication of Advanced Reproductive Age (37-42) in Patients Undergoing ART
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 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Screening
Condition  ICMJE Infertility
Intervention  ICMJE 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
Study Arms  ICMJE
  • No Intervention: 1
    Control: assisted hatching, without Preimplantation Genetic Diagnosis
  • Experimental: 2
    Test: embryo biopsy with Preimplantation Genetic Diagnosis
    Intervention: Procedure: Preimplantation Genetic Diagnosis (PGD)
Publications * Colls P, Escudero T, Cekleniak N, Sadowy S, Cohen J, Munné S. Increased efficiency of preimplantation genetic diagnosis for infertility using "no result rescue". Fertil Steril. 2007 Jul;88(1):53-61. Epub 2007 Feb 12.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Suspended
Estimated Enrollment  ICMJE
 (submitted: March 28, 2008)
1200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2011
Estimated Primary Completion Date January 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 37 Years to 42 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain,   United States
Removed Location Countries Turkey
 
Administrative Information
NCT Number  ICMJE NCT00646893
Other Study ID Numbers  ICMJE Reprogenetics-01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Santiago Munne, Reprogenetics
Study Sponsor  ICMJE Reprogenetics
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Santiago Munne, PhD Reprogenetics
PRS Account Reprogenetics
Verification Date February 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP