Status:
TERMINATED
Impact of Parental Support on Pregnancy Outcomes (IPSO) Trial- Day 3 Preimplantation Genetic Screening (PGS) With Day 5 Fresh Transfer
Lead Sponsor:
Natera, Inc.
Collaborating Sponsors:
Ferring Pharmaceuticals
Conditions:
Preimplantation Gentic Screening (PGS)
In Vitro Fertilization (IVF)
Eligibility:
FEMALE
35-42 years
Phase:
PHASE4
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...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2013
Estimated Enrollment :
59 Patients enrolled
Trial Details
Trial ID
NCT01194531
Start Date
September 1 2010
End Date
April 1 2013
Last Update
November 25 2014
Active Locations (9)
Enter a location and click search to find clinical trials sorted by distance.
1
Huntington Reproductive Center
Laguna Hills, California, United States, 92653
2
Shady Grove Fertility RSC
Washington D.C., District of Columbia, United States, 20006
3
Florida Fertility Institute/ Women's Medical Research Group, LLC
Clearwater, Florida, United States, 33759
4
Atlanta Center for Reproductive Medicine
Atlanta, Georgia, United States, 30328