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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
  Purpose
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
Infertility Procedure: Assisted embryo hatching

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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.
  Eligibility

Information from the National Library of Medicine

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

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00120549


Locations
United States, Maryland
Shady Grove Fertility Reproductive Science Center
Rockville, Maryland, United States, 20850
Sponsors and Collaborators
Shady Grove Fertility Reproductive Science Center
Investigators
Principal Investigator: Eric A Widra, MD Shady Grove Fertility Reproductive Science Center
  More Information

ClinicalTrials.gov Identifier: NCT00120549     History of Changes
Other Study ID Numbers: 1588 WIRB
First Submitted: July 11, 2005
First Posted: July 18, 2005
Last Update Posted: December 9, 2005
Last Verified: July 2005

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

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female