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Study of Assisted Hatching of Cleavage Stage Embryos

Primary Purpose

Infertility

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Assisted embryo hatching
Sponsored by
Shady Grove Fertility Reproductive Science Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility focused on measuring Assisted Hatching, Cleavage Stage, Ovum, Embryo Transfer, Pregnancy, Embryo Implantation

Eligibility Criteria

18 Years - 39 Years (Adult)FemaleDoes not accept 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

Sites / Locations

  • Shady Grove Fertility Reproductive Science Center

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
July 11, 2005
Last Updated
July 15, 2005
Sponsor
Shady Grove Fertility Reproductive Science Center
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1. Study Identification

Unique Protocol Identification Number
NCT00120549
Brief Title
Study of Assisted Hatching of Cleavage Stage Embryos
Official Title
Prospective Randomized Trial of Assisted Hatching of Cleavage Stage Embryos
Study Type
Interventional

2. Study Status

Record Verification Date
July 2005
Overall Recruitment Status
Completed
Study Start Date
August 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Shady Grove Fertility Reproductive Science Center

4. Oversight

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
Assisted Hatching, Cleavage Stage, Ovum, Embryo Transfer, Pregnancy, Embryo Implantation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
200 (false)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Assisted embryo hatching
Primary Outcome Measure Information:
Title
Clinical pregnancy (with fetal cardiac activity) at 5 to 6 weeks after embryo transfer

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
39 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric A Widra, MD
Organizational Affiliation
Shady Grove Fertility Reproductive Science Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shady Grove Fertility Reproductive Science Center
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20850
Country
United States

12. IPD Sharing Statement

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Study of Assisted Hatching of Cleavage Stage Embryos

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