SuspendedPhase 4

Preimplantation Genetic Diagnosis for the Indication of Advanced Reproductive Age

Stopped: lack of appropriate funding

United States, Spain1,200 participantsStarted 2008-06

Plain-language summary

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.

Who can participate

Age range37 Years – 42 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

What they're measuring

ongoing pregnancy rate (past 2nd trimester).

Timeframe: after 21 days, 20 weeks, and 7 month of treatment

Trial details

NCT IDNCT00646893

SponsorReprogenetics

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2011-01