NCT00646893

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.

Trial Health

37
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
1,200

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jun 2008

Typical duration for phase_4

Geographic Reach
2 countries

5 active sites

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 26, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 31, 2008

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2008

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
Last Updated

February 23, 2010

Status Verified

February 1, 2010

Enrollment Period

2.6 years

First QC Date

March 26, 2008

Last Update Submit

February 21, 2010

Conditions

Infertility

Keywords

aneuploidymiscarriagepregnancy lossPGDPGSPreimplantation Genetic Diagnosischromosome abnormalitiesIVFART

Outcome Measures

Primary Outcomes (1)

  • ongoing pregnancy rate (past 2nd trimester).

    after 21 days, 20 weeks, and 7 month of treatment

Secondary Outcomes (3)

  • spontaneous abortions

    within 1st and 2nd trimester

  • pregnancy

    one month for presence of fetal sac

  • implantation

    first month, for presence of fetal sacs

Study Arms (2)

1

NO INTERVENTION

Control: assisted hatching, without Preimplantation Genetic Diagnosis

2

EXPERIMENTAL

Test: embryo biopsy with Preimplantation Genetic Diagnosis

Procedure: Preimplantation Genetic Diagnosis (PGD)

Interventions

Preimplantation Genetic Diagnosis (PGD)PROCEDURE

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
2

Eligibility Criteria

Age37 Years - 42 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

ART Reproductive Center,

Beverly Hills, California, 90210, United States

Location

Fertility Centers of Illinois

Highland Park, Illinois, 60035, United States

Location

Institute for Reproductive Medicine and Science at Saint Barnabas Medical Center

Livingston, New Jersey, 07039, United States

Location

Reprogenetics

Livingston, New Jersey, 07039, United States

Location

IVI Barcelona

Barcelona, Barcelona, Spain

Location

Related Publications (1)

  • 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.

    PMID: 17296179BACKGROUND

MeSH Terms

Conditions

InfertilityAneuploidyAbortion, SpontaneousChromosome Aberrations

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy Complications

Study Officials

  • Santiago Munne, PhD

    Reprogenetics

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 26, 2008

First Posted

March 31, 2008

Study Start

June 1, 2008

Primary Completion

January 1, 2011

Study Completion

April 1, 2011

Last Updated

February 23, 2010

Record last verified: 2010-02

Locations

US(4)ES(1)