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

A Prospective Randomized Clinical Trial to Determine the Efficacy of 24 Chromosome Preimplantation Genetic Diagnosis

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01219283

Enrollment

334

Registered

2010-10-13

Start date

2009-08-31

Completion date

2013-06-30

Last updated

2015-03-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Effect of PGD on Implantation Rates in IVF Cycles

Keywords

PGD, IVF

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).

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

21 Years to 43 Years

Healthy volunteers

Yes

Inclusion 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)

Design outcomes

Primary

Measure	Time frame	Description
Sustained Implantation Rate Per Embryo Transferred	Within 1 year	Implantation rate per embryo transferred

Secondary

Measure	Time frame	Description
Clinical Pregnancy Rate and Delivery Rate per Treatment Cycle	Within 1 Year	Clinical Pregnancy Rate and Delivery Rate per Treatment Cycle

Countries

United States

Outcome results