InfertilityNCT02802176
Comparing Intra-vaginal Culture of Embryos to In-vitro Culture of Embryos With Minimal Stimulation
A study testing INVOcell device and Traditional IVF in people with Infertility, run by University of California, San Francisco at 1 site in United States.
Trial summary
The purpose of this study is to evaluate implantation rate with intra-vaginal culture (IVC) with the INVOcell device versus traditional In-Vitro Fertilization (IVF) while using minimal stimulation protocols Read more about this study
- Who is it for?
- Ages 18 to 37 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility
- What is being tested?
- INVOcell device and Traditional IVF
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2016to 25 Aug 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 37 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Normal uterine cavity
- One or more years of infertility
- Normal male partner semen analysis
Who cannot join
- Age <18 years old or >37 years old
- Antral Follicle Count (AFC) <8
- Abnormal male partner semen analysis or use of donor sperm
- Vaginal inflammation or genital (vaginal, uterine, tubal) infection
- Uncontrolled chronic disease (such as uncontrolled diabetes or hypertension)
- Uterine anatomic abnormalities
Show all 11Show fewer
- Allergy to plastics or inability to use diaphragm retention device
- Untreated hydrosalpinx
- Current alcohol abuse (defined by >14 drinks/week)
- Prior history of IVF cycle where fertilization did not occur
- History of recurrent pregnancy loss
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California San Francisco - Center for Reproductive Health
San Francisco, California, 94158
About this study
Official title: Randomized Controlled Trial Comparing Intra-vaginal Culture of Embryos Using INVOcell Device to In-vitro Culture of Embryos Using Minimal Stimulation Protocols
The purpose of this study is to evaluate implantation rate with intra-vaginal culture (IVC) with the INVOcell device versus traditional In-Vitro Fertilization (IVF) while using minimal stimulation protocols
Read the detailed description
This is a Phase IV, single center randomized controlled trial evaluating intra-vaginal culture (IVC) using INVOcell versus traditional In-Vitro Fertilization (IVF) using oral stimulation or minimal gonadotropin stimulation protocols. The pilot aims to includes 40 women who will be randomized to either the intra-vaginal culture group (N=20) using INVOcell or to the traditional IVF group (N=20).
Primary aim is implantation rate, which is defined by number gestational sacs seen on early pregnancy ultrasound divided by number of embryos transferred.
Secondary aims are:
- Embryo quality, which is measured by system similar to the Gardner grading system at cleavage stage. Reported quality will be converted to the simplified SART embryo scoring system which provides an overall categorical embryo grade of "Good", "Fair" or "Poor".
- Fertilization rate, which is defined by the total number of fertilized oocytes divided by total number of mature oocytes retrieved. This comparison will take place on day-3, as that is when the IVC embryos will be assessed.
- Clinical pregnancy rate, which is defined by the number of fetal poles with heartbeat seen on ultrasound divided by the number of embryos transferred.
- Live birth rate, which is defined by the number of living babies delivered divided by the number of transfers
- Conditions
- Infertility
- Being tested
- INVOcell device, Traditional IVF
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INVOcell deviceDevice
intra-vaginal culture of embryos using INVOcell device
Traditional IVFOther
traditional culture of embryos in-vitro
| Study group | Role | What they receive |
|---|---|---|
| Intra-vaginal culture - INVOcell device | Experimental | 3 day intra-vaginal incubation using the INVOcell device Receives: Device: INVOcell device |
| Traditional IVF culture | Active comparator | 3 day traditional IVF incubation Receives: Other: Traditional IVF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implantation Rate
defined by number gestational sacs seen on early pregnancy ultrasound typically done at 6 weeks of gestational age divided by number of embryos transferred
Measured: approximately 4 weeks following randomization. Clinically this is typically done around 6 weeks of gestational age
Secondary outcomes (4)
Embryo Quality
-Embryo quality, which is measured by system similar to the Gardner grading system at cleavage stage. Reported quality will be converted to the simplified SART embryo scoring system which provides an overall categorical embryo grade of "Good", "Fair" or "Poor".
Measured: measured after 3 days of incubation
Fertilization Rate
defined by the total number of fertilized oocytes divided by total number of mature oocytes retrieved
Measured: measured after 3 days of incubation
Clinical Pregnancy Rate
which is defined by the number of fetal poles with heartbeat seen on early pregnancy ultrasound typically done at 6 weeks of gestational age divided by the number of embryos transferred
Measured: approximately 4 weeks following randomization. Clinically this is typically done around 6 weeks of gestational age
Live Birth Rate
which is defined by the number of living babies delivered divided by the number of transfers
Measured: 9 months 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 posted16 Jun 2016 (estimated)
- Study startOct 2016
- Primary completion20 Apr 2022
- Study completion25 Aug 2022
Why it stopped: Slow enrollment and completion of screening qualifiers.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for InfertilityStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- 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
- Model description
- Arm 1: intra-vaginal culture using INVOcell device. Arm 2: Traditional In-Vitro Fertilization (IVF) culture in an embryology laboratory
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marcelle Cedars, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02802176
- Sponsor's protocol ID
- IRB 166094
- Status last verified
- Jun 2023
- First submitted
- 12 Jun 2016
- Last updated
- 12 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial Comparing Intra-vaginal Culture of Embryos Using INVOcell Device to In-vitro Culture of Embryos Using Minimal Stimulation Protocols
- ClinicalTrials.gov ID
- NCT02802176
- Acronym / sponsor ID
- IRB 166094
- Conditions
- Infertility
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow enrollment and completion of screening qualifiers.
- Enrolment
- 39 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Oct 2016 (actual)
- Primary completion
- 20 Apr 2022 (actual)
- Study completion
- 25 Aug 2022 (actual)
- First posted
- 16 Jun 2016 (estimated)
- Results
- Posted 12 Jul 2023
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 is to evaluate implantation rate with intra-vaginal culture (IVC) with the INVOcell device versus traditional In-Vitro Fertilization (IVF) while using minimal stimulation protocols
Detailed description
This is a Phase IV, single center randomized controlled trial evaluating intra-vaginal culture (IVC) using INVOcell versus traditional In-Vitro Fertilization (IVF) using oral stimulation or minimal gonadotropin stimulation protocols. The pilot aims to includes 40 women who will be randomized to either the intra-vaginal culture group (N=20) using INVOcell or to the traditional IVF group (N=20).
Primary aim is implantation rate, which is defined by number gestational sacs seen on early pregnancy ultrasound divided by number of embryos transferred.
Secondary aims are:
- Embryo quality, which is measured by system similar to the Gardner grading system at cleavage stage. Reported quality will be converted to the simplified SART embryo scoring system which provides an overall categorical embryo grade of "Good", "Fair" or "Poor".
- Fertilization rate, which is defined by the total number of fertilized oocytes divided by total number of mature oocytes retrieved. This comparison will take place on day-3, as that is when the IVC embryos will be assessed.
- Clinical pregnancy rate, which is defined by the number of fetal poles with heartbeat seen on ultrasound divided by the number of embryos transferred.
- Live birth rate, which is defined by the number of living babies delivered divided by the number of transfers
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Arm 1: intra-vaginal culture using INVOcell device. Arm 2: Traditional In-Vitro Fertilization (IVF) culture in an embryology laboratory
| Arm | Type | Receives |
|---|---|---|
| Intra-vaginal culture - INVOcell device | Experimental | Device: INVOcell device3 day intra-vaginal incubation using the INVOcell device |
| Traditional IVF culture | Active comparator | Other: Traditional IVF3 day traditional IVF incubation |
Who may qualify
- Ages
- 18 to 37 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Normal uterine cavity
- One or more years of infertility
- Normal male partner semen analysis
Key exclusion criteria (11 listed)
- Age <18 years old or >37 years old
- Antral Follicle Count (AFC) <8
- Abnormal male partner semen analysis or use of donor sperm
- Vaginal inflammation or genital (vaginal, uterine, tubal) infection
- Uncontrolled chronic disease (such as uncontrolled diabetes or hypertension)
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 |
|---|---|---|
| INVOcell deviceintra-vaginal culture of embryos using INVOcell device | Device | Intra-vaginal culture - INVOcell device |
| Traditional IVFtraditional culture of embryos in-vitro | Other | Traditional IVF culture |
Primary outcome
Implantation Rate
Time frame: approximately 4 weeks following randomization. Clinically this is typically done around 6 weeks of gestational age
defined by number gestational sacs seen on early pregnancy ultrasound typically done at 6 weeks of gestational age divided by number of embryos transferred
4 secondary outcomes
Embryo Quality
Time frame: measured after 3 days of incubation
Fertilization Rate
Time frame: measured after 3 days of incubation
Clinical Pregnancy Rate
Time frame: approximately 4 weeks following randomization. Clinically this is typically done around 6 weeks of gestational age
Live Birth Rate
Time frame: 9 months after embryo transfer
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- University of California San Francisco Center for Reproductive HealthLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Marcelle Cedars, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing INVOcell device and Traditional IVF in people with Infertility, run by University of California, San Francisco 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 11 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: stopped early, as of the sponsor's last update on 12 Jul 2023. 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?
Yes. Results are posted in the registry (first posted 12 Jul 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Implantation Rate (time frame: approximately 4 weeks following randomization. Clinically this is typically done around 6 weeks of gestational age). 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 12 Jul 2023.