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Study of Assisted Hatching of Cleavage Stage Embryos

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00120549
First Posted: July 18, 2005
Last Update Posted: December 9, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Shady Grove Fertility Reproductive Science Center
July 11, 2005
July 18, 2005
December 9, 2005
August 2001
Not Provided
Clinical pregnancy (with fetal cardiac activity) at 5 to 6 weeks after embryo transfer
Same as current
Complete list of historical versions of study NCT00120549 on ClinicalTrials.gov Archive Site
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Study of Assisted Hatching of Cleavage Stage Embryos
Prospective Randomized Trial of Assisted Hatching of Cleavage Stage Embryos
The purpose of this study was to determine if assisted embryo hatching can improve pregnancy rates for good prognosis patients undergoing in vitro fertilization (IVF) with day 3 embryo transfer.
Assisted hatching is a procedure in which a hole is made in the hard covering of a developing embryo to allow the embryo to hatch more easily from this shell. This procedure is sometimes used before transferring embryos to patients after in vitro fertilization (IVF) in an attempt to improve resulting pregnancy rates. Assisted hatching has been shown to improve outcomes among certain groups of patients, such as older patients or patients with a history of IVF treatment and embryo transfer without success. Whether this procedure could benefit the broader patient population remains unclear. The purpose of this study was to evaluate potential benefits of assisted hatching for good prognosis patients who would not typically be treated with assisted hatching under current standard protocols. Pregnancy rates were compared between good prognosis patients undergoing IVF with day-3 embryo transfer with or without assisted hatching of the transferred embryos.
Interventional
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Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Infertility
Procedure: Assisted embryo hatching
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
200
March 2005
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Inclusion Criteria:

  • IVF patients with day 3 embryo transfer
  • Maximum age of 39 years
  • Maximum FSH 9 mIU/ml
  • Maximum E2 75 pg/ml
  • Ovulatory menstrual cycles
  • Good embryo quality

Exclusion Criteria:

  • Diagnosis of diminished ovarian reserve, polycystic ovarian syndrome, uterine or egg factor infertility
  • More than one previous unsuccessful IVF cycle
Sexes Eligible for Study: Female
18 Years to 39 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00120549
1588 WIRB
Not Provided
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Shady Grove Fertility Reproductive Science Center
Not Provided
Principal Investigator: Eric A Widra, MD Shady Grove Fertility Reproductive Science Center
Shady Grove Fertility Reproductive Science Center
July 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP