Study of Assisted Hatching of Cleavage Stage Embryos

Not Applicable

Completed

• Conditions: Infertility

• Registration Number: NCT00120549
• Lead Sponsor: Shady Grove Fertility Reproductive Science Center

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.

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 Timeline

• Study Start: 2001-08
• Study Completion: 2005-03
• Status Verified: 2005-07
• Study First Submitted: 2005-07-11
• Study First Submitted QC: 2005-07-11
• Last Update Submitted: 2005-07-15
• Study First Posted: 2005-07-18
• Last Update Posted: 2005-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Clinical pregnancy (with fetal cardiac activity) at 5 to 6 weeks after embryo transfer

Trial Locations

Locations (1)

Shady Grove Fertility Reproductive Science Center; 🇺🇸 Rockville, Maryland, United States