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Study of Assisted Hatching of Cleavage Stage Embryos

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ClinicalTrials.gov Identifier: NCT00120549
Recruitment Status : Completed
First Posted : July 18, 2005
Last Update Posted : July 19, 2005
Sponsor:
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment
Infertility Procedure: Assisted embryo hatching

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Prospective Randomized Trial of Assisted Hatching of Cleavage Stage Embryos
Study Start Date : August 2001
Estimated Study Completion Date : March 2005
Arms and Interventions


Outcome Measures

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

Eligibility Criteria

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 Posted: July 18, 2005    Key Record Dates
Last Update Posted: July 19, 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