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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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)

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

Intervention / Treatment
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* Device: 24 Chromosome Aneuploidy Screening with Parental Support


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 42 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: CONTROL arm<br>Subjects assigned to this arm of the study will receive no PGS testing. | |
| Other: TEST arm<br>Subjects assigned to this arm of the study will receive PGS testing. | Device: 24 Chromosome Aneuploidy Screening with Parental Support<br>* Preimplantation Genetic Screening (PGS)<br>* Other names: Preimplantation Genetic Diagnosis (PGD);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Preimplantation Gentic Screening, PGS, In Vitro Fertilization, IVF, Preimplantation Genetic Diagnosis, PGD