InfertilityGES/FETNCT00694434
Graduated Embryo Score (GES) in the Fresh Cycle Predicts Outcome From Frozen Embryo Transfer
An observational study of Infertility, run by Sher Institute for Reproductive Medicine, Las Vegas at 1 site in United States.
Trial summary
Evaluation of embryo quality in the fresh cycle as a predictor of outcome from frozen embryo transfer. Read more about this study
- Who is it for?
- Ages 21 to 44 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility
- How many people
- 183 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2002to Dec 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 44 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: All IVF patients at our center between 2002 and 2007 with at least 2 frozen blastocysts undergoing frozen embryo transfer.
Who may be able to join
- 2 frozen blastocysts
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Sher Institute for Reproductive Medicine
Las Vegas, Nevada, 89118
About this study
Official title: Graduated Embryo Score (GES) Int he Fresh Cycle Predicts Outcome From Frozen Embryo Transfer
Evaluation of embryo quality in the fresh cycle as a predictor of outcome from frozen embryo transfer.
Read the detailed description
Outcomes from frozen embryo transfer reviewed based on the quality of the embryos in the ftresh cycle as assessed by the Graduatede embryo score.
- Conditions
- Infertility
- Keywords
- Cryopreservation, Frozen embryo transfer, Graduated Embryo Score
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Patients with 2 or more frozen blastocyst that scored GES 70 or better in the fresh cycle. | |
| 2 | Patients with 2 or more frozen blastocysts scoring GES <70 in the fresh cycle. |
What is being measured
The primary outcome is the main question the study is designed to answer.
On-going gestation (beyond 8 wks)
Measured: Fetal heart activity at 8 weeks of gestation
Secondary outcomes (1)
Implantation rate (gestational sacs/ embryos transferred)
Measured: 8 weeks of gestation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2008 (estimated)
- Study startJan 2002
- Primary completionDec 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 183 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sher Institute for Reproductive Medicine, Las Vegas
- Sponsor type
- University, hospital or other
- Investigators
- Jeffrey D Fisch, M.D., Principal investigator, Sher Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00694434
- Sponsor's protocol ID
- 1-Fisch
- Acronym
- GES/FET
- Status last verified
- Jun 2008
- First submitted
- 6 Jun 2008
- Last updated
- 10 Jun 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Graduated Embryo Score (GES) Int he Fresh Cycle Predicts Outcome From Frozen Embryo Transfer
- ClinicalTrials.gov ID
- NCT00694434
- Acronym / sponsor ID
- GES/FET / 1-Fisch
- Conditions
- Infertility
- Keywords
- Cryopreservation, Frozen embryo transfer, Graduated Embryo Score
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 183 participants (actual)
- Lead sponsor
- Sher Institute for Reproductive Medicine, Las VegasUniversity, hospital or other
- Study start
- Jan 2002
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 10 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluation of embryo quality in the fresh cycle as a predictor of outcome from frozen embryo transfer.
Detailed description
Outcomes from frozen embryo transfer reviewed based on the quality of the embryos in the ftresh cycle as assessed by the Graduatede embryo score.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Patients with 2 or more frozen blastocyst that scored GES 70 or better in the fresh cycle. |
| 2 | – | –Patients with 2 or more frozen blastocysts scoring GES <70 in the fresh cycle. |
Who may qualify
- Ages
- 21 to 44 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- All IVF patients at our center between 2002 and 2007 with at least 2 frozen blastocysts undergoing frozen embryo transfer.
Key inclusion criteria (1 listed)
- 2 frozen blastocysts
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
On-going gestation (beyond 8 wks)
Time frame: Fetal heart activity at 8 weeks of gestation
1 secondary outcome
Implantation rate (gestational sacs/ embryos transferred)
Time frame: 8 weeks of gestation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey D Fisch, M.D. principal investigator
Sher Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility, run by Sher Institute for Reproductive Medicine, Las Vegas at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jun 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
On-going gestation (beyond 8 wks) (time frame: Fetal heart activity at 8 weeks of gestation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2008.