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Completed

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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Key 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

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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

  1. Impact of biopsy on pregnancy

    Time frame: 1 year

    Impact of the biopsy of the embryo on whether a pregnancy is obtained

  2. 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.