Status:
SUSPENDED
Preimplantation Genetic Diagnosis for the Indication of Advanced Reproductive Age
Lead Sponsor:
Reprogenetics
Conditions:
Infertility
Eligibility:
FEMALE
37-42 years
Phase:
PHASE4
Brief 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 matern...
Detailed Description
Indications: Patients of advanced reproductive age wishing to receive preimplantation genetic screening in ART. Objectives: To demonstrate that Preimplantation Genetic diagnosis (PGD) will significan...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2011
Estimated Enrollment :
1200 Patients enrolled
Trial Details
Trial ID
NCT00646893
Start Date
June 1 2008
End Date
April 1 2011
Last Update
February 23 2010
Active Locations (5)
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1
ART Reproductive Center,
Beverly Hills, California, United States, 90210
2
Fertility Centers of Illinois
Highland Park, Illinois, United States, 60035
3
Institute for Reproductive Medicine and Science at Saint Barnabas Medical Center
Livingston, New Jersey, United States, 07039
4
Reprogenetics
Livingston, New Jersey, United States, 07039