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

History of Changes

Tracking Information
First Received Date ^ICMJE	August 2, 2010
Last Updated Date	May 6, 2013
Start Date ^ICMJE	September 2010
Primary Completion Date	April 2013 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: December 9, 2010)	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.
Original Primary Outcome Measures ^ICMJE (submitted: September 1, 2010)	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.
Change History	Complete list of historical versions of study NCT01194531 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Impact of Parental Support on Pregnancy Outcomes (IPSO) Trial- Day 3 Preimplantation Genetic Screening (PGS) With Day 5 Fresh Transfer
Official Title ^ICMJE	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)
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.
Study Type ^ICMJE	Interventional
Study Phase	Phase 4
Study Design ^ICMJE	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Screening
Condition ^ICMJE	Preimplantation Gentic Screening (PGS) In Vitro Fertilization (IVF) Preimplantation Genetic Diagnosis (PGD)
Intervention ^ICMJE	Device: 24 Chromosome Aneuploidy Screening with Parental Support Preimplantation Genetic Screening (PGS) Other Name: Preimplantation Genetic Diagnosis (PGD)
Study Arm (s)	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. Intervention: Device: 24 Chromosome Aneuploidy Screening with Parental Support
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Terminated
Enrollment ^ICMJE	58
Completion Date	April 2013
Primary Completion Date	April 2013 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Female
Ages	35 Years to 42 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01194531
Other Study ID Numbers ^ICMJE	IVF006-D3
Has Data Monitoring Committee	No
Responsible Party	Natera, Inc.
Study Sponsor ^ICMJE	Natera, Inc.
Collaborators ^ICMJE	Ferring Pharmaceuticals
Investigators ^ICMJE	Not Provided
Information Provided By	Natera, Inc.
Verification Date	May 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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