Evaluation of the Impact of Embryo Biopsy on the Reproductive Potential of Embryos Undergoing In Vitro Fertilization (IVF)

1 Embryo Will be Biopsied and 1 Embryo is Not Clinical Trial

Official title:

Evaluation of the Impact of Embryo Biopsy on the Reproductive Potential of Embryos Undergoing IVF

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01219504
• Other study ID #: RMA-00-17
• Status: Completed
• Phase: N/A
• First received: October 8, 2010
• Last updated: January 22, 2013
• Start date: April 2008
• Est. completion date: September 2012

Study information

• Verified date: January 2013
• Source: Reproductive Medicine Associates of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

To assess the impact of embryo biopsy on the reproductive potential of human embryos.

Description:

This study will recruit patients from the NY/NJ/CT/eastern PA area only.

All patients will undergo an in vitro fertilization (IVF) cycle with hormonal stimulation and an egg retrieval procedure as deemed appropriate for their diagnosis. Following biopsy, the embryos will be transferred. There will be no delay in the time of transfer as no cells will be analyzed prior to transfer.

On day 3 or day 5 of embryo development, all patients will undergo a two (2) embryo transfer. The embryos selected for transfer will be the 2 morphologically best of the embryo cohort. Once selected for transfer, the embryos will be randomized so that one will be biopsied and the other will be transferred without undergoing biopsy. The embryo randomized to biopsy will have a single cell biopsied.

Following delivery, buccal swabs will be collected from infants.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 35 Years

Eligibility

This study will recruit patients from the NY/NJ/CT/eastern PA area only.

Inclusion Criteria:

1. Maximum of one prior failed IVF treatment cycle

2. Female partner less than 35 years of age

3. Normal day 3 FSH level (<10 miu/mL)

4. Total basal antral follicle count greater than or equal to 12

5. Male partner with greater than 100,000 total motile spermatozoa and at least 1% normal forms

6. Body mass index (BMI) < or = 32

7. Normal uterine cavity

Exclusion Criteria:

1. Diagnosis of chronic anovulation secondary to polycystic ovarian disease

2. Diagnosis of endometrial insufficiency

3. Clinical indication for pre-implantation genetic diagnosis (PGD) (undergoing IVF with PGD to rule out a known genetic defect)

4. Use of testicular aspiration or biopsy procedures to obtain sperm

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• 1 Embryo Will be Biopsied and 1 Embryo is Not
• Each Patient is Both Case and Control

Locations

Country	Name	City	State
United States	Reproductive Medicine Associates of New Jersey	Morristown	New Jersey
United States	Reproductive Medicine Associates of New York	New York	New Jersey
United States	Reproductive Medicine Associates of Connecticut	Norfolk	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Reproductive Medicine Associates of New Jersey

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Impact of biopsy on pregnancy	Impact of the biopsy of the embryo on whether a pregnancy is obtained	1 year	No
Primary	Impact of biopsy on delivery	Impact of the biopsy on pregnancy resulting in delivery	1 year	No

External Links

•   Reproductive Medicine Associates of New Jersey