NCT Number: NCT01219504
Evaluation of the Impact of Embryo Biopsy on the Reproductive Potential of Embryos Undergoing In Vitro Fertilization (IVF)
To assess the impact of embryo biopsy on the reproductive potential of human embryos.
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Notify MeKey information
Age range
18 year–35 year
Sex eligibility
All sexes
Study type
Observational
Primary location
Reproductive Medicine Associates of Connecticut, Norfolk, Connecticut, United States
About this study
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.
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
This study will recruit patients from the NY/NJ/CT/eastern PA area only.
Inclusion criteria
- Maximum of one prior failed IVF treatment cycle
- Female partner less than 35 years of age
- Normal day 3 FSH level (<10 miu/mL)
- Total basal antral follicle count greater than or equal to 12
- Male partner with greater than 100,000 total motile spermatozoa and at least 1% normal forms
- Body mass index (BMI) < or = 32
- Normal uterine cavity
Exclusion criteria
- Diagnosis of chronic anovulation secondary to polycystic ovarian disease
- Diagnosis of endometrial insufficiency
- Clinical indication for pre-implantation genetic diagnosis (PGD) (undergoing IVF with PGD to rule out a known genetic defect)
- Use of testicular aspiration or biopsy procedures to obtain sperm
Treatment and study plan
Primary outcomes
-
Impact of biopsy on pregnancy
Time frame: 1 year
Impact of the biopsy of the embryo on whether a pregnancy is obtained
-
Impact of biopsy on delivery
Time frame: 1 year
Impact of the biopsy on pregnancy resulting in delivery
Sponsors and collaborators
Lead sponsor
Reproductive Medicine Associates of New Jersey
Other
Registry information
Official study title
Evaluation of the Impact of Embryo Biopsy on the Reproductive Potential of Embryos Undergoing IVF
Important dates
- Study start
- 2008
- Primary completion
- 2012
- Study completion
- 2012
- First posted
- Oct 13, 2010
- Registry last updated
- Jan 23, 2013
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.