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

NCT01194531 | Terminated Phase 4 Results

• 1 other identifier: IVF006-D3
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 9

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Implantation Rate

  Implantation rate is defined as the ratio between the number of gestational sacs with a fetal heartbeat and the total number of embryos transferred.

  Data is collected at approximately 4-6 weeks gestation, 20 weeks gestation and 40 weeks gestation.

Study Arms (2)

CONTROL arm

NO INTERVENTION

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

TEST arm

OTHER

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

Device: 24 Chromosome Aneuploidy Screening with Parental Support

Interventions

24 Chromosome Aneuploidy Screening with Parental Support DEVICE

Preimplantation Genetic Screening (PGS)

Also known as: Preimplantation Genetic Diagnosis (PGD)

TEST arm

Eligibility Criteria

• Age: 35 Years - 42 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• FSH ≥10 IU/L within past year prior to screening
• 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

Sponsors & Collaborators

• Natera, Inc.: lead
• Ferring Pharmaceuticals: collaborator

Study Sites (9)

Huntington Reproductive Center

Laguna Hills, California, 92653, United States

Location

Shady Grove Fertility RSC

Washington D.C., District of Columbia, 20006, United States

Location

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

Clearwater, Florida, 33759, United States

Location

Atlanta Center for Reproductive Medicine

Atlanta, Georgia, 30328, United States

Location

Fertility Centers of Illinois

Chicago, Illinois, 60610, United States

Location

Boston IVF

Boston, Massachusetts, 02451, United States

Location

The Nevada Center for Reproductive Medicine

Reno, Nevada, 89511, United States

Location

Main Line Fertility

Bryn Mawr, Pennsylvania, 19010-3121, United States

Location

Fertility Specialist of Houston

Houston, Texas, 77054, United States

Location

MeSH Terms

Interventions

Preimplantation Diagnosis

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Obstetrical and Gynecological; Diagnostic Techniques and Procedures; Diagnosis

Results Point of Contact

• Title: Nina Wemmer, MS,CGC, Study Coordinator
• Organization: Natera (formerly Gene Security Network)

nwemmer@natera.com

650-249-9090

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2010
• First Posted: September 3, 2010
• Study Start: September 1, 2010
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: November 25, 2014
• Results First Posted: November 13, 2014

Record last verified: 2014-11

Locations

US (9)