Study of the Efficacy of 24 Chromosome Preimplantation Genetic Diagnosis (PGD)

Completed

• Conditions: Effect of PGD on Implantation Rates in IVF Cycles

• Registration Number: NCT01219283
• Lead Sponsor: Reproductive Medicine Associates of New Jersey

Brief Summary

The purpose of this study is to determine if 24 chromosome preimplantation genetic diagnosis (PGD) increases implantation and delivery rates in couples attempting to conceive through in vitro fertilization (IVF).

Detailed Description

FISH based PGD techniques have provided little improvement in implantation and delivery rates. We believe that the use of 24 chromosome PGD, as compared to control (no PGD) will show a benefit to patients. This study is a randomized clinical trial that seeks to validate 24 chromosome PGD.

Patients that meet the eligibility criteria will be randomized prior to embryo transfer. In order to be randomized, the patient must have blastulated embryos suitable for biopsy on day 5. Half of the patients will received 24 chromosome PGD and will have 2 PGD normal embryos transferred. Half the the patients will receive no PGD and the 2 morphologically best embryos will be transferred. Follow up on pregnant patients will be a blood draw at approximately 9 weeks gestation and buccal swabs collected from the infant(s).

Study Timeline

• Study Start: 2009-08
• Study First Submitted: 2010-10-08
• Study First Submitted QC: 2010-10-12
• Study First Posted: 2010-10-13
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-25
• Last Update Posted: 2015-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 334

Inclusion Criteria

1. Age of female partner of < 43 years
2. Normal day-three FSH level (< 15 mIU/mL)
3. Normal uterine cavity
4. Sufficient ejaculated spermatozoa in male partner for ART
5. Maximum of one prior failed IVF cycle

Major

Exclusion Criteria

1. FSH level ≥ 15 mIU/mL
2. BMI greater than 32 kg/m2
3. Contraindication to gonadotropin stimulation
4. Unevaluated Ovarian mass
5. Need for surgical sperm removal
6. Any contraindication to undergoing in vitro fertilization
7. Age greater than 43 years
8. Presence of hydrosalpinges which communicate with the endometrial cavity
9. Clinical indication for PGD (undergoing IVF with PGD to rule out a known genetic defect)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sustained Implantation Rate Per Embryo Transferred	Within 1 year	Implantation rate per embryo transferred

Secondary Outcome Measures

Name	Time	Method
Clinical Pregnancy Rate and Delivery Rate per Treatment Cycle	Within 1 Year	Clinical Pregnancy Rate and Delivery Rate per Treatment Cycle

Trial Locations

Locations (3)

Colorado Center for Reproductive Medicine; 🇺🇸 Lone Tree, Colorado, United States

Reproductive Medicine Associates of PA at Lehigh Valley; 🇺🇸 Allentown, Pennsylvania, United States

Reproductive Medicine Associates; 🇺🇸 Morristown, New Jersey, United States