Impact of Parental Support on Pregnancy Outcomes (IPSO) Trial- Day 3 Preimplantation Genetic Screening (PGS) With Day 5 Fresh Transfer

This study has been terminated.
(Slow enrollment and Natera is transitioning to a new PGS testing platform.)
Sponsor:
Collaborator:
Ferring Pharmaceuticals
Information provided by (Responsible Party):
Natera, Inc.
ClinicalTrials.gov Identifier:
NCT01194531
First received: August 2, 2010
Last updated: May 6, 2013
Last verified: May 2013
  Purpose

Natera is recruiting patients for a research study evaluating pregnancy and implantation rates in women undergoing In Vitro Fertilization (IVF) and Preimplantation Genetic Screening (PGS). PGS is also referred to as Preimplantation Genetic Diagnosis (PGD) for aneuploidy.

Healthy women undergoing IVF who are between the ages of 35 to 42 years are being recruited to participate in a randomized study.

The purpose of this study is to determine whether PGS- testing of embryos created during IVF for chromosomal abnormalities, prior to transfer to the uterus- improves pregnancy and implantation rates in patients when compared to patients whose embryos are not tested. PGS will be conducted using 24 Chromosome Aneuploidy Screening with Parental Support from Natera.

All subjects who qualify and enroll will receive discounted IVF medications (both TEST and CONTROL arms). If you become pregnant during the study, you will receive a small payment for providing information about your pregnancy and birth. If you are assigned to the TEST arm of the study you will receive free PGS.


Condition Intervention Phase
Preimplantation Gentic Screening (PGS)
In Vitro Fertilization (IVF)
Preimplantation Genetic Diagnosis (PGD)
Device: 24 Chromosome Aneuploidy Screening with Parental Support
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Screening
Official Title: IPSO Trial - Impact of Parental Support on Pregnancy Outcomes: A Multi-Center, Randomized, Open-Label Study to Evaluate the Implantation and Pregnancy Rates Following 24 Chromosome Aneuploidy Screening With Parental Support in Patients Undergoing In Vitro Fertilization (IVF)

Further study details as provided by Natera, Inc.:

Primary Outcome Measures:
  • Implantation rate [ Time Frame: Data is collected at approximately 4-6 weeks gestation, 20 weeks gestation and 40 weeks gestation. ] [ Designated as safety issue: No ]
    Implantation rate is defined as the ratio between the number of gestational sacs with a fetal heartbeat and the total number of embryos transferred.


Enrollment: 58
Study Start Date: September 2010
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: CONTROL arm
Subjects assigned to this arm of the study will receive no PGS testing.
TEST arm
Subjects assigned to this arm of the study will receive PGS testing.
Device: 24 Chromosome Aneuploidy Screening with Parental Support
Preimplantation Genetic Screening (PGS)
Other Name: Preimplantation Genetic Diagnosis (PGD)

Detailed Description:

If you meet the criteria below, you may be a candidate for this study. To participate in the study you must:

  • Be a healthy, pre-menopausal female, 35-42 years of age
  • Have a history of less than 3 consecutive miscarriages and no more than one failed IVF cycle
  • Agree to use Ferring Pharmaceutical products during stimulation
  • Agree to be randomly assigned to either the arm of the study receiving PGS (TEST arm)or the arm receiving no additional testing (CONTROL arm)

Additional screening will be conducted to determine if you are eligible to enroll.

All subjects who qualify and enroll will receive discounted IVF medications. If you become pregnant during the study, you will receive a small payment for providing information about your pregnancy and birth. If you are assigned to the TEST arm of the study you will receive free PGS.

  Eligibility

Ages Eligible for Study:   35 Years to 42 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Must agree to a follow-up visit at approximately 4-8 weeks gestation and a follow up phone call at 20 and 40 weeks gestation/livebirth. For patients assigned to the TEST group must agree to PGD testing and collection of buccal swab sample on newborn
  • At least 10 eggs retrieved
  • Must agree to use only Ferring products during stimulation
  • Normal uterine cavity detected on hysterosalpingogram (HSG), saline infusion sonogram (SIS), or hysteroscopy
  • Signed consent form

Exclusion Criteria:

  • FSH ≥10 IU/L within past year prior to screening
  • 2 or more previously failed IVF cycles
  • Gestational or surrogate carrier, donor oocyte, donor sperm
  • History of recurrent pregnancy loss (3 or more consecutive miscarriages)
  • Severe male factor infertility defined as ejaculate sperm of < 1million sperm/ml, or sperm obtained through testicular biopsy
  • Gender selection as primary indication
  • Maternal disease that is not clinically stable and known to impact the ability to become pregnant or carry a pregnancy to term (lupus, chronic liver or kidney disease, body mass index (BMI) >35, uncontrolled hypertension, anti-phospholipid antibody, thrombophilia, insulin dependent diabetes)
  • Refusal or inability to comply with the requirements of the Protocol for any reason, including scheduled clinic visits and laboratory tests
  • Participation in any experimental drug study within 30 days prior to Screening
  • Prior hypersensitivity to any of the protocol drugs
  • Known history conveying increased risk for chromosome abnormality (beyond maternal age) or genetic disease in offspring
  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: NCT01194531

Locations
United States, California
Huntington Reproductive Center
Laguna Hills, California, United States, 92653
United States, District of Columbia
Shady Grove Fertility RSC
Washington, District of Columbia, United States, 20006
United States, Florida
Florida Fertility Institute/ Women's Medical Research Group, LLC
Clearwater, Florida, United States, 33759
United States, Georgia
Atlanta Center for Reproductive Medicine
Atlanta, Georgia, United States, 30328
United States, Illinois
Fertility Centers of Illinois
Chicago, Illinois, United States, 60610
United States, Massachusetts
Boston IVF
Boston, Massachusetts, United States, 02451
United States, Nevada
The Nevada Center for Reproductive Medicine
Reno, Nevada, United States, 89511
United States, Pennsylvania
Main Line Fertility
Bryn Mawr, Pennsylvania, United States, 19010-3121
United States, Texas
Fertility Specialist of Houston
Houston, Texas, United States, 77054
Sponsors and Collaborators
Natera, Inc.
Ferring Pharmaceuticals
  More Information

Additional Information:
No publications provided

Responsible Party: Natera, Inc.
ClinicalTrials.gov Identifier: NCT01194531     History of Changes
Other Study ID Numbers: IVF006-D3
Study First Received: August 2, 2010
Last Updated: May 6, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Natera, Inc.:
Preimplantation Gentic Screening
PGS
In Vitro Fertilization
IVF
Preimplantation Genetic Diagnosis
PGD

ClinicalTrials.gov processed this record on August 26, 2014