Study of Assisted Hatching of Cleavage Stage Embryos - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

July 11, 2005

Last Updated Date

July 15, 2005

Start Date ^†

August 2001

Current Primary Outcome Measures ^†

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

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00120549 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Original Secondary Outcome Measures ^†

Descriptive Information

Brief Title ^†

Study of Assisted Hatching of Cleavage Stage Embryos

Official Title ^†

Prospective Randomized Trial of Assisted Hatching of Cleavage Stage Embryos

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 Phase

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study

Condition ^†

Infertility

Intervention ^†

Procedure: Assisted embryo hatching

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

200

Completion Date

March 2005

Primary Completion Date

Eligibility 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

Gender

Female

Ages

18 Years to 39 Years

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00120549

Responsible Party

Secondary IDs ^††

Study Sponsor ^†

Shady Grove Fertility Reproductive Science Center

Collaborators ^††

Investigators ^†

Principal Investigator:

Eric A Widra, MD

Shady Grove Fertility Reproductive Science Center

Information Provided By

Shady Grove Fertility Reproductive Science Center

Verification Date

July 2005

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.