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SuspendedNCT00646893Updated Feb 23, 2010

Preimplantation Genetic Diagnosis for the Indication of Advanced Reproductive Age

A Phase 4 interventional study of Preimplantation Genetic Diagnosis (PGD) in Infertility, sponsored by Reprogenetics. Suspended at 5 sites in 2 countries. Open to female participants aged 37 Years to 42 Years. Per ClinicalTrials.gov, last updated 2010-02-23.

Sponsored by Reprogenetics (part of CooperCompanies) · Phase 4, Interventional, and Screening

Why this study was suspended
lack of appropriate funding
Phase
Phase 4
Study type
Interventional
Enrollment
1,200
Allocation
Randomized
Ages
37 Years to 42 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Infertility

Keywords

  • aneuploidy
  • miscarriage
  • pregnancy loss
  • PGD
  • PGS
  • Preimplantation Genetic Diagnosis
  • chromosome abnormalities
  • IVF
  • ART
03

In context

Infertility

2,541 studies on the registry are indexed under Infertility; 405 are open to participants now.

This study's planned enrollment of 1,200 is above the median of 120 across 1,722 interventional studies indexed under Infertility.

Browse Infertility studies →

Lead sponsor

Reprogenetics is the lead sponsor of 6 studies on the registry; none are open to participants now.

First submitted before Reprogenetics became part of CooperCompanies.

Browse Reprogenetics studies →All CooperCompanies studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
37 Years to 42 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Phase 4
Primary purpose
Screening
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
1,200 participants (estimated)

Study arms

  • No intervention
    1

    Control: assisted hatching, without Preimplantation Genetic Diagnosis

  • Experimental
    2

    Test: embryo biopsy with Preimplantation Genetic Diagnosis

    Procedure: Preimplantation Genetic Diagnosis (PGD)

Interventions

  • ProcedurePreimplantation 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)

    Also known as: PGS, Preimplantation Genetic Screening

06

What researchers measure

Primary outcomes

  1. ongoing pregnancy rate (past 2nd trimester).

    Time frame: after 21 days, 20 weeks, and 7 month of treatment

Secondary outcomes

  1. spontaneous abortions

    Time frame: within 1st and 2nd trimester

  2. pregnancy

    Time frame: one month for presence of fetal sac

  3. implantation

    Time frame: first month, for presence of fetal sacs

07

Study locations

5 sites
  • ART Reproductive Center,
    Beverly Hills, California 90210, United States
  • Fertility Centers of Illinois
    Highland Park, Illinois 60035, United States
  • Institute for Reproductive Medicine and Science at Saint Barnabas Medical Center
    Livingston, New Jersey 07039, United States
  • Reprogenetics
    Livingston, New Jersey 07039, United States
  • IVI Barcelona
    Barcelona, Barcelona, Spain
08

References and documents

Publications

  • Colls P, Escudero T, Cekleniak N, Sadowy S, Cohen J, Munne S. Increased efficiency of preimplantation genetic diagnosis for infertility using "no result rescue". Fertil Steril. 2007 Jul;88(1):53-61. doi: 10.1016/j.fertnstert.2006.11.099. Epub 2007 Feb 12. PubMed 17296179 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jun 2008, a primary completion of Jan 2011 and a completion of Apr 2011. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 26, 2008
First posted
Mar 31, 2008
Start
Jun 2008
Primary completionEst.
Jan 2011
CompletionEst.
Apr 2011
Last update
Feb 23, 2010
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 23, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00646893
Lead sponsor
Reprogenetics
First posted
Mar 31, 2008
Start date
Jun 2008
Primary completion
Jan 2011 (estimated)
Completion
Apr 2011 (estimated)
Last update
Feb 23, 2010

Study contacts

Santiago Munne, PhD
principal investigator · Reprogenetics

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is suspended, as verified in Feb 2010. You cannot join it, but the record below documents what was studied.

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