MedDataX Logo

Study of Assisted Hatching of Cleavage Stage Embryos

NCT ID: NCT00120549

Last Updated: 2005-07-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-08-31

Study Completion Date

2005-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Infertility

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Assisted Hatching Cleavage Stage, Ovum Embryo Transfer Pregnancy Embryo Implantation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Assisted embryo hatching

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

39 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Shady Grove Fertility Reproductive Science Center

OTHER

Sponsor Role lead

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Eric A Widra, MD

Role: PRINCIPAL_INVESTIGATOR

Shady Grove Fertility Reproductive Science Center

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Shady Grove Fertility Reproductive Science Center

Rockville, Maryland, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

1588 WIRB

Identifier Type: -

Identifier Source: org_study_id