Study of Assisted Hatching of Cleavage Stage Embryos

Prospective Randomized Trial of Assisted Hatching of Cleavage Stage Embryos

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00120549

Enrollment

200

Registered

2005-07-18

Start date

2001-08-31

Completion date

2005-03-31

Last updated

2005-07-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertility

Keywords

Assisted Hatching, Cleavage Stage, Ovum, Embryo Transfer, Pregnancy, Embryo Implantation

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.

Interventions

PROCEDUREAssisted embryo hatching

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 39 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Clinical pregnancy (with fetal cardiac activity) at 5 to 6 weeks after embryo transfer	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026