InfertilityNCT02028897
Comparison of Alternative Embryo Culture Systems
A study testing Conventional embryo culture and Enclosed embryo culture in people with Infertility, run by Bruce Shapiro M.D. at 1 site in United States.
Trial summary
This study will compare two alternative embryo culture systems. Embryos from each patient will be randomly assigned to one of two systems. One group will be cultured conventionally in oil-covered droplets in dishes. The other group will be assigned to an enclosed system. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility
- What is being tested?
- Conventional embryo culture and Enclosed embryo culture
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Start not givento Jan 2015
- 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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female age 18 to 40, seeking IVF treatment
- Ability to understand English (to obtain informed consent)
- Use of an oocyte donor, sperm donor, gestational carrier, and/or genetic testing (with blastocyst biopsy only) are allowed.
Who cannot join
- Diminished ovarian reserve as evidenced by either elevated cycle day 3 follicle stimulating hormone (FSH) level (≥10 IU/L) or low antral follicle count (<8 antral follicles)
- Fewer than five (5) bipronuclear oocytes
- Day 3 embryo biopsy for any reason
- No minors may enroll
Trial locations and contacts
1 site in 1 country.
United States1 site
Fertility Center of Las Vegas
Las Vegas, Nevada, 89117
About this study
This study will compare two alternative embryo culture systems. Embryos from each patient will be randomly assigned to one of two systems. One group will be cultured conventionally in oil-covered droplets in dishes. The other group will be assigned to an enclosed system.
Read the detailed description
Qualifying and consenting IVF patients will have approximately half of their developing embryos cultured in droplets covered with oil. The other approximate half of their embryos will be cultured in small enclosed containers. Embryo assignments will be at random. Regardless of culture system, all embryos will be cultured from the bipronuclear stage to the blastocyst stage in the same (Global) media, without the usual refreshing of media on day 3.
- Conditions
- Infertility
- Being tested
- Conventional embryo culture, Enclosed embryo culture
- Keywords
- In vitro fertilization, IVF, Embryo culture, Blastocyst transfer
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional embryo cultureOther
Enclosed embryo cultureOther
| Study group | Role | What they receive |
|---|---|---|
| Conventional embryo culture | Active comparator | Conventional embryo culture in dishes, in droplets under oil. Receives: Other: Conventional embryo culture |
| Alternative embryo culture | Experimental | Embryo culture in system using small enclosed containers Receives: Other: Enclosed embryo culture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blastulation rate
Proportion of cultured embryos that form blastocysts.
Measured: 5 days (sixth day of embryo development)
Secondary outcomes (2)
Blastocyst morphology
Inner cell mass size, number of trophectoderm cells, blastocyst diameter
Measured: 5 days (sixth day of development)
IVF outcome
The result of the IVF cycle as no pregnancy, early pregnancy loss, or ongoing pregnancy at 10 weeks gestation (about 7 weeks post-transfer).
Measured: 7 weeks post-transfer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2014 (estimated)
- Primary completionJan 2015 (estimated)
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
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bruce Shapiro M.D.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor-investigator, Bruce Shapiro M.D., Fertility Center of Las Vegas
- Investigators
- Bruce Shapiro, MD, PhD, Principal investigator, Fertility Center of Las Vegas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02028897
- Sponsor's protocol ID
- SAIRB-13-0040
- Status last verified
- Jan 2015
- First submitted
- 6 Jan 2014
- Last updated
- 8 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Alternative Embryo Culture Systems
- ClinicalTrials.gov ID
- NCT02028897
- Acronym / sponsor ID
- SAIRB-13-0040
- Conditions
- Infertility
- Keywords
- In vitro fertilization, IVF, Embryo culture, Blastocyst transfer
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Bruce Shapiro M.D.Industry (pharma, biotech, devices)
- Primary completion
- Jan 2015 (estimated)
- First posted
- 7 Jan 2014 (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.
This study will compare two alternative embryo culture systems. Embryos from each patient will be randomly assigned to one of two systems. One group will be cultured conventionally in oil-covered droplets in dishes. The other group will be assigned to an enclosed system.
Detailed description
Qualifying and consenting IVF patients will have approximately half of their developing embryos cultured in droplets covered with oil. The other approximate half of their embryos will be cultured in small enclosed containers. Embryo assignments will be at random. Regardless of culture system, all embryos will be cultured from the bipronuclear stage to the blastocyst stage in the same (Global) media, without the usual refreshing of media on day 3.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional embryo culture | Active comparator | Other: Conventional embryo cultureConventional embryo culture in dishes, in droplets under oil. |
| Alternative embryo culture | Experimental | Other: Enclosed embryo cultureEmbryo culture in system using small enclosed containers |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Female age 18 to 40, seeking IVF treatment
- Ability to understand English (to obtain informed consent)
- Use of an oocyte donor, sperm donor, gestational carrier, and/or genetic testing (with blastocyst biopsy only) are allowed.
Key exclusion criteria (4 listed)
- Diminished ovarian reserve as evidenced by either elevated cycle day 3 follicle stimulating hormone (FSH) level (≥10 IU/L) or low antral follicle count (<8 antral follicles)
- Fewer than five (5) bipronuclear oocytes
- Day 3 embryo biopsy for any reason
- No minors may enroll
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 |
|---|---|---|
| Conventional embryo culture | Other | Conventional embryo culture |
| Enclosed embryo culture | Other | Alternative embryo culture |
Primary outcome
Blastulation rate
Time frame: 5 days (sixth day of embryo development)
Proportion of cultured embryos that form blastocysts.
2 secondary outcomes
Blastocyst morphology
Time frame: 5 days (sixth day of development)
IVF outcome
Time frame: 7 weeks post-transfer
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2015.
Related trials for Infertility
RecruitingObservational study
International Pilot Study for Dual Non-invasive Assesment of Embryo Development
Infertility
Active, not recruitingObservational study
Retrieval of Sperm From Men With Azoospermia Using Ultrasound-guided Rete Testis Aspiration
Azoospermia, Nonobstructive, Infertility, Male
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)
RecruitingObservational study
Impact of Infertility on the Sexual Sphere in Couples Undergoing Assisted Reproduction
Sexual Health Quality of Life, Infertile Patients
RecruitingObservational study
Pilot Study of Discarded Blastocysts
Infertility (IVF Patients)
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.
Bruce Shapiro, MD, PhD principal investigator
Fertility Center of Las Vegas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional embryo culture and Enclosed embryo culture in people with Infertility, run by Bruce Shapiro M.D. 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 3 inclusion and 4 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: withdrawn, as of the sponsor's last update on 8 Jan 2015. 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 was withdrawn before enrolling participants, so there are no results.
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?
Blastulation rate (time frame: 5 days (sixth day of embryo development)). 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 8 Jan 2015.