InfertilityNCT00120549
Study of Assisted Hatching of Cleavage Stage Embryos
A study testing Assisted embryo hatching in people with Infertility, run by Shady Grove Fertility Reproductive Science Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 39 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- Assisted embryo hatching
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2001to Mar 2005
- Phase
- Interventional
- 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 18 to 39 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- Diagnosis of diminished ovarian reserve, polycystic ovarian syndrome, uterine or egg factor infertility
- More than one previous unsuccessful IVF cycle
Trial locations and contacts
1 site in 1 country.
United States1 site
Shady Grove Fertility Reproductive Science Center
Rockville, Maryland, 20850
About this study
Official title: Prospective Randomized Trial of Assisted Hatching of Cleavage Stage Embryos
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.
Read the 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.
- Conditions
- Infertility
- Being tested
- Assisted embryo hatching
- Keywords
- Assisted Hatching, Cleavage Stage, Ovum, Embryo Transfer, Pregnancy, Embryo Implantation
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assisted embryo hatchingProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical pregnancy (with fetal cardiac activity) at 5 to 6 weeks after embryo transfer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2005 (estimated)
- Study startAug 2001
- Study completionMar 2005
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 200 participants
Sponsor and investigators
- Lead sponsor
- Shady Grove Fertility Reproductive Science Center
- Sponsor type
- University, hospital or other
- Investigators
- Eric A Widra, MD, Principal investigator, Shady Grove Fertility Reproductive Science Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00120549
- Sponsor's protocol ID
- 1588 WIRB
- Status last verified
- Jul 2005
- First submitted
- 11 Jul 2005
- Last updated
- 19 Jul 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Trial of Assisted Hatching of Cleavage Stage Embryos
- ClinicalTrials.gov ID
- NCT00120549
- Acronym / sponsor ID
- 1588 WIRB
- Conditions
- Infertility
- Keywords
- Assisted Hatching, Cleavage Stage, Ovum, Embryo Transfer, Pregnancy, Embryo Implantation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants
- Lead sponsor
- Shady Grove Fertility Reproductive Science CenterUniversity, hospital or other
- Study start
- Aug 2001
- Study completion
- Mar 2005
- First posted
- 18 Jul 2005 (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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 39 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- Diagnosis of diminished ovarian reserve, polycystic ovarian syndrome, uterine or egg factor infertility
- More than one previous unsuccessful IVF cycle
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Assisted embryo hatching | Procedure or surgery | – |
Primary outcome
Clinical pregnancy (with fetal cardiac activity) at 5 to 6 weeks after embryo transfer
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 19 Jul 2005.
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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.
Eric A Widra, MD principal investigator
Shady Grove Fertility Reproductive Science Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Assisted embryo hatching in people with Infertility, run by Shady Grove Fertility Reproductive Science Center 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 6 inclusion and 2 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 19 Jul 2005. 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?
Clinical pregnancy (with fetal cardiac activity) at 5 to 6 weeks after embryo transfer. 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 19 Jul 2005.