NCT00120549

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2001

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2001

Completed
3.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2005

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 11, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 18, 2005

Completed
Last Updated

July 19, 2005

Status Verified

July 1, 2005

First QC Date

July 11, 2005

Last Update Submit

July 15, 2005

Conditions

Infertility

Keywords

Assisted HatchingCleavage Stage, OvumEmbryo TransferPregnancyEmbryo Implantation

Outcome Measures

Primary Outcomes (1)

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

Interventions

Assisted embryo hatchingPROCEDURE

Eligibility Criteria

Age18 Years - 39 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Diagnosis of diminished ovarian reserve, polycystic ovarian syndrome, uterine or egg factor infertility
  • More than one previous unsuccessful IVF cycle

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shady Grove Fertility Reproductive Science Center

Rockville, Maryland, 20850, United States

Location

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Eric A Widra, MD

    Shady Grove Fertility Reproductive Science Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 11, 2005

First Posted

July 18, 2005

Study Start

August 1, 2001

Study Completion

March 1, 2005

Last Updated

July 19, 2005

Record last verified: 2005-07

Locations

US(1)