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 range

37 Years – 42 Years

Sex

FEMALE

See this in plain English?

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

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