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Study of Assisted Hatching of Cleavage Stage Embryos

This study has been completed.
Information provided by:
Shady Grove Fertility Reproductive Science Center Identifier:
First received: July 11, 2005
Last updated: July 15, 2005
Last verified: July 2005
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.

Condition Intervention
Procedure: Assisted embryo hatching

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Prospective Randomized Trial of Assisted Hatching of Cleavage Stage Embryos

Further study details as provided by Shady Grove Fertility Reproductive Science Center:

Primary Outcome Measures:
  • Clinical pregnancy (with fetal cardiac activity) at 5 to 6 weeks after embryo transfer

Estimated Enrollment: 200
Study Start Date: August 2001
Estimated Study Completion Date: March 2005
Detailed Description:
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.

Ages Eligible for Study:   18 Years to 39 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00120549

United States, Maryland
Shady Grove Fertility Reproductive Science Center
Rockville, Maryland, United States, 20850
Sponsors and Collaborators
Shady Grove Fertility Reproductive Science Center
Principal Investigator: Eric A Widra, MD Shady Grove Fertility Reproductive Science Center
  More Information Identifier: NCT00120549     History of Changes
Other Study ID Numbers: 1588 WIRB
Study First Received: July 11, 2005
Last Updated: July 15, 2005

Keywords provided by Shady Grove Fertility Reproductive Science Center:
Assisted Hatching
Cleavage Stage, Ovum
Embryo Transfer
Embryo Implantation

Additional relevant MeSH terms:
Genital Diseases, Male
Genital Diseases, Female processed this record on May 25, 2017