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

Reproductive Medicine Associates of New Jersey

Status: Completed

Conditions: Effect of PGD on Implantation Rates in IVF Cycles

Study type: Observational

Funder types: Other

Identifiers

NCT01219283

RCT-2009-01

Details and patient eligibility

About

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).

Full 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).

Enrollment: 334 patients

Sex: Female

Ages: 21 to 43 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Major 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)

Trial design

334 participants in 2 patient groups

Control (no PGD)

Description:

Receive their planned IVF treatment without PGD. 2 morphologically best embryos are transferred.

Case (PGD)

Description:

Receive PGD in addition to their planned IVF Cycle. 2 morphologically best PGD normal embryos are transferred.