Preimplantation Genetic Diagnosis for the Indication of Advanced Reproductive Age

Paused · Phase 4

Conditions studied: Infertility

In brief

The objective of this study is to demonstrate that Preimplantation Genetic diagnosis will significantly reduce spontaneous abortions and increase ongoing pregnancy rates in patients of advanced maternal age (37-42) undergoing IVF. We would like to test this hypothesis by a randomized trial performed with the most suitable conditions using very successful IVF laboratories capable to perform the embryo biopsy under strict controlled conditions after proper training and validation of the techniques.

Key facts

Study ID

NCT00646893

Run by

Reprogenetics

People needed

1200

Starts

2008-06-01

Expected to finish

2011-04-01

Last updated by the study team

2010-02-23

Who can join

Age: 37 and older, up to 42. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Premenopausal infertile women wishing to conceive
• Aged 37 42 years, inclusive,
• Regular menstrual cycles (generally 25 35 days in length) and screening early follicular phase FSH within normal limits.

You may not qualify if…

• Clinically significant systemic disease;
• Any contraindication to pregnancy or carrying pregnancy to term;
• Known ASRM Grade III or IV endometriosis;
• Clinically significant abnormal findings on a transvaginal ultrasound within 6 weeks prior to the beginning of OCP treatment;
• Extrauterine pregnancy within 3 months prior to the beginning of OCP treatment;
• ≥ 3 prior, initiated, consecutive ART cycles without a clinical pregnancy;
• Prior severe OHSS;
• TESA and TESE patients;
• Patients carriers of chromosomal or genetic diseases.
• Egg donation cycles.
• Frozen Cycles.

Where it is running

• ART Reproductive Center, — Beverly Hills, California, United States
• Fertility Centers of Illinois — Highland Park, Illinois, United States
• Institute for Reproductive Medicine and Science at Saint Barnabas Medical Center — Livingston, New Jersey, United States
• Reprogenetics — Livingston, New Jersey, United States
• IVI Barcelona — Barcelona, Barcelona, Spain

Full record on ClinicalTrials.gov

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