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

NCT ID: NCT01194531

Last Updated: 2014-11-25

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 59 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-09-30
• Study Completion Date: 2013-04-30

Brief Summary

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.

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.

Conditions

Preimplantation Gentic Screening (PGS); In Vitro Fertilization (IVF); Preimplantation Genetic Diagnosis (PGD)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

CONTROL arm

Subjects assigned to this arm of the study will receive no PGS testing.

Group Type: NO_INTERVENTION

No interventions assigned to this group

TEST arm

Subjects assigned to this arm of the study will receive PGS testing.

Group Type: OTHER

24 Chromosome Aneuploidy Screening with Parental Support

Intervention Type: DEVICE

Preimplantation Genetic Screening (PGS)

Interventions

24 Chromosome Aneuploidy Screening with Parental Support

Preimplantation Genetic Screening (PGS)

Intervention Type: DEVICE

Other Intervention Names

Preimplantation Genetic Diagnosis (PGD)

Eligibility 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

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 42 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Ferring Pharmaceuticals

INDUSTRY

Sponsor Role: collaborator

Natera, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Huntington Reproductive Center

Laguna Hills, California, United States

Shady Grove Fertility RSC

Washington D.C., District of Columbia, United States

Florida Fertility Institute/ Women's Medical Research Group, LLC

Clearwater, Florida, United States

Atlanta Center for Reproductive Medicine

Atlanta, Georgia, United States

Fertility Centers of Illinois

Chicago, Illinois, United States

Boston IVF

Boston, Massachusetts, United States

The Nevada Center for Reproductive Medicine

Reno, Nevada, United States

Main Line Fertility

Bryn Mawr, Pennsylvania, United States

Fertility Specialist of Houston

Houston, Texas, United States

Countries

United States

Other Identifiers

IVF006-D3

Identifier Type: -

Identifier Source: org_study_id