Study of Assisted Hatching of Cleavage Stage Embryos
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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 Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
Official Title: | Prospective Randomized Trial of Assisted Hatching of Cleavage Stage Embryos |
- 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 |
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 |
Genders 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
United States, Maryland | |
Shady Grove Fertility Reproductive Science Center | |
Rockville, Maryland, United States, 20850 |
Principal Investigator: | Eric A Widra, MD | Shady Grove Fertility Reproductive Science Center |
No publications provided
ClinicalTrials.gov Identifier: | NCT00120549 History of Changes |
Other Study ID Numbers: | 1588 WIRB |
Study First Received: | July 11, 2005 |
Last Updated: | July 15, 2005 |
Health Authority: | United States: Institutional Review Board |
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 |
ClinicalTrials.gov processed this record on October 16, 2012