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

Completed

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

• Registration Number: NCT01219504
• Lead Sponsor: Reproductive Medicine Associates of New Jersey

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2008-04
• Study First Submitted: 2010-10-08
• Study First Submitted QC: 2010-10-12
• Study First Posted: 2010-10-13
• Primary Completion: 2012-09
• Study Completion: 2012-09
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-22
• Last Update Posted: 2013-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Impact of biopsy on delivery	1 year	Impact of the biopsy on pregnancy resulting in delivery
Impact of biopsy on pregnancy	1 year	Impact of the biopsy of the embryo on whether a pregnancy is obtained

Trial Locations

Locations (3)

Reproductive Medicine Associates of New York; 🇺🇸 New York, New Jersey, United States

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

Reproductive Medicine Associates of Connecticut; 🇺🇸 Norfolk, Connecticut, United States