InfertilityPhase 3NCT02363426
Vaginal Culture Using INVOcell Compared to Traditional IVF Incubation
A Phase 3 study testing INVOcell Culture Device and IVF Incubation in people with Infertility, run by Invaron Pharmaceuticals Inc. at 1 site in United States.
Trial summary
The purpose of this study is to evaluate intravaginal culture using the medical device INVOcell to generate day 5 blastocysts in comparison to traditional IVF. Read more about this study
- Who is it for?
- Ages 18 to 38 yearsHealthy volunteers can take part
- Conditions the study is for
- Infertility
- What is being tested?
- INVOcell Culture Device and IVF Incubation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to Jan 2016
- Phase
- Phase 3
- 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 38 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Couples who will participate to the study will be pre selected for the following major indications:
- Women diagnosed with:
- Tubal factor
- Endometriosis (type I to II)
- Ovulatory dysfunction (slight)
- Multiple female factors (<2)
Show all 22Show fewer
- Males with slight male factor
- Couples with:
- Unknown factor
- Multiple factors, from female and male origin (<2)
- Other rare factors not excluded by the inclusion/exclusion criteria (e.g. cervical mucus immune factor not treatable by IUI)
- The pre-selected couples will be included in the study only if they fulfill the more specific inclusion and exclusion criteria below.
- Couples may be included in the study only if they have been informed about the study and have given their written consent.
- Infertile couple with failure to conceive a recognized pregnancy after one year (or 12 menstrual cycles) of unprotected intercourse IVF has been determined by the physician to be their next treatment
- Women included in the study should:
- Be between the age of 18 and 38 (up to 38th birthday at the time of the enrollment).
- Have had a normal gynecological examination and Pap smear in the last 12 months.
- Have a normal follicle stimulating hormone (<10 mIU/mL) and E2 (<250 pmol/L) on Day 3, determined in the past 12 months
- Have an anti-mullerian hormone >1 or <3 ng/mL
- Have had a normal baseline pelvic ultrasound examination in the past 12 months
- Have a normal uterine cavity as assessed in the past year by hysterosalpingogram, sonohysterography or hysteroscopy. Prior tubal ligation is acceptable.
- Have had negative cervical tests for G.C and Chlamydia in the past 12 months. Have male partner with a normal semen analysis with a total number of > 15 million total motile spermatozoa with normal morphology or borderline normal morphology (> 3% with the strict criteria) and a progression rating of >2.
Who cannot join
- Women to be excluded from this study are those who have:
- Inability to read and speak English fluently
- A history of recurrent vaginitis
- A history of toxic shock syndrome
- Known allergies to plastic, human serum proteins or gentamicin
- Had pelvic surgery within the past 8 weeks, excluding diagnostic laparoscopy
Show all 29Show fewer
- Pelvic inflammatory disease (PID) within the past 3 months and were treated with antibiotics
- Severe endometriosis (stage III-IV) or endometriomas (past or present)
- Clinical signs of vaginal infection
- Significant abnormalities of the vaginal cavity
- Sub mucus or intramural fibroids (>1 cm diameter)
- Hydrosalpinx
- Chronic illness, e.g. autoimmune disease, diabetes
- BMI >36
- Donor oocytes, donor sperm
- antral follicle count < 6 or > 20
- Anti-Mullerian Hormone <1 or >3
- Previously responded poorly to ovarian stimulation and polycystic ovary patients
- High responder to ovarian stimulation
- Cervical stenosis, as demonstrated by failed mock embryo transfer
- Cannot tolerate a speculum examination
- Unwilling or unable to wear a retention system (diaphragm) during the 5 days of incubation.
- > 2 previously failed IVF (neg βhCG)
- Previously failed fertilization of all oocytes previous IVF cycle
- Smoke or abuse drugs and alcohol
- Poor understanding of the procedure
- Partner with vasectomy reversal
- Partner with difficulty in producing sperm specimen
- Partner with uro-genital infection. Sperm culture will be performed if the partner shows or has shown some symptoms of uro-genital infection.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Open-Label Non-Inferiority Trial Comparing Day 5 Embryos Derived From Intravaginal Culture Using the Medical Device INVOcell to Traditional In Vitro Fertilization
The purpose of this study is to evaluate intravaginal culture using the medical device INVOcell to generate day 5 blastocysts in comparison to traditional IVF.
Read the detailed description
This is a Phase III, single center, open label randomized comparative trial to evaluate intravaginal culture using INVOcell vs. traditional IVF to generate day 5 embryos Pilot: 40 couples (80 patients), randomized to receive either intravaginal culture (n=20) using the INVOcell or traditional IVF (n=20) Primary Endpoints: Blastocyst generation rate: number of day 5 embryos of "good quality" defined as 2BB or greater (expansion of embryo 2,3,4,5 or 6 and inner cell mass and outer cell mass grades of A or B) or higher using the Gardner Grading System divided by the number of eggs incubated Patient acceptability of INVOcell and intravaginal culture.
Secondary Endpoints: Live birth rate: number of cycles with a live birth divided by the number of cycles with embryo transfers.
Clinical pregnancy rate: number of cycles with fetal heartbeat at week 7 divided by the number of cycles with embryo transfers.
Fertilization rate: Number of embryos obtained after incubation divided by the number of oocytes placed in the device.
Embryo transfer rate: Number of cycles initiated divided by the number of cycles with embryo transfers Miscarriage rate: Number of miscarriages divided by the number of cycles with embryo transfers Multiple rate: Number cycles with twins or triplets divided by the number of cycles with embryo transfers Miscarriage rate per clinical pregnancy: Number of miscarriages divided by the number of cycles with clinical pregnancy
- Conditions
- Infertility
- Being tested
- INVOcell Culture Device, IVF Incubation
- Keywords
- intravaginal culture, in vitro fertilization, blastocyst, pregnancy
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INVOcell Culture DeviceDevice
Also called INVOcell, INVOcell Culture Device
INVOcell is a vaginal culture device
IVF IncubationDevice
IVF Incubator
| Study group | Role | What they receive |
|---|---|---|
| Medical Device: INVOcell Culture Device | Other | 5 day oocyte incubation using INVOcell Culture Device within the vaginal cavity. Receives: Device: INVOcell Culture Device |
| Medical Device: IVF Incubator | Active comparator | 5 day oocyte incubation using traditional IVF incubation. Receives: Device: IVF Incubation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blastocyst Quality
Blastocyst generation rate: number of day 5 embryos of "good quality" defined as 2BB or greater (expansion of embryo 2,3,4,5 or 6 and inner cell mass and outer cell mass grades of A or B) or higher using the Gardner Grading System divided by the number of eggs incubated
Measured: Measures assessed following 5 days incubation, approximately 17 days following randomization
Secondary outcomes (7)
Patient Acceptability
Patient acceptability of INVOcell and intravaginal culture using a 12 point subjective and quantitative questionnaire.
Measured: Measures assessed at first followup visit following embryo transfer, approximately 9 weeks post randomization
Live Birth Rate
Live birth rate: number of cycles with a live birth divided by the number of cycles with embryo transfers.
Measured: Measures assessed 9 months post embryo transfer, approximately 9 months and two weeks following randomization
Clinical Pregnancy Rate
Clinical pregnancy rate: number of cycles with fetal heartbeat at week 7 divided by the number of cycles with embryo transfers.
Measured: Measures assessed approximately 16 days following embryo transfer, approximately 4 weeks following randomization.
Fertilization Rate
Fertilization rate: Number of embryos obtained after incubation divided by the number of oocytes placed in the device.
Measured: Measures assessed following 5 days post incubation, approximately 2 and 1/2 weeks post randomization.
Embryo Transfer Rate
Embryo transfer rate: Number of cycles initiated divided by the number of cycles with embryo transfers
Measured: Measures assessed following 5 days incubation, approximately 2 and 1/2 weeks following randomization.
Miscarriage Rate
Miscarriage rate: Number of miscarriages divided by the number of cycles with embryo transfers
Measured: Measures assessed following embryo transfer and a maximum of 9 months gestation.
Multiple Rate
Multiple rate: Number cycles with twins or triplets divided by the number of cycles with embryo transfers
Measured: Measures assessed 9 months after the last subject received an embryo transfer, once all live birth data is known for each embryo.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2015 (estimated)
- Study startJan 2013
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Invaron Pharmaceuticals Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02363426
- Sponsor's protocol ID
- CP-006
- Status last verified
- Jan 2016
- First submitted
- 5 Feb 2015
- Last updated
- 20 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Ranoux C, Aubriot FX, Dubuisson JB, Cardone V, Foulot H, Poirot C, Chevallier O. A new in vitro fertilization technique: intravaginal culture. Fertil Steril. 1988 Apr;49(4):654-7. doi: 10.1016/s0015-0282(16)59835-5.
PubMed 3350160
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Open-Label Non-Inferiority Trial Comparing Day 5 Embryos Derived From Intravaginal Culture Using the Medical Device INVOcell to Traditional In Vitro Fertilization
- ClinicalTrials.gov ID
- NCT02363426
- Acronym / sponsor ID
- CP-006
- Conditions
- Infertility
- Keywords
- intravaginal culture, in vitro fertilization, blastocyst, pregnancy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Invaron Pharmaceuticals Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2013
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 16 Feb 2015 (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 is to evaluate intravaginal culture using the medical device INVOcell to generate day 5 blastocysts in comparison to traditional IVF.
Detailed description
This is a Phase III, single center, open label randomized comparative trial to evaluate intravaginal culture using INVOcell vs. traditional IVF to generate day 5 embryos Pilot: 40 couples (80 patients), randomized to receive either intravaginal culture (n=20) using the INVOcell or traditional IVF (n=20) Primary Endpoints: Blastocyst generation rate: number of day 5 embryos of "good quality" defined as 2BB or greater (expansion of embryo 2,3,4,5 or 6 and inner cell mass and outer cell mass grades of A or B) or higher using the Gardner Grading System divided by the number of eggs incubated Patient acceptability of INVOcell and intravaginal culture.
Secondary Endpoints: Live birth rate: number of cycles with a live birth divided by the number of cycles with embryo transfers.
Clinical pregnancy rate: number of cycles with fetal heartbeat at week 7 divided by the number of cycles with embryo transfers.
Fertilization rate: Number of embryos obtained after incubation divided by the number of oocytes placed in the device.
Embryo transfer rate: Number of cycles initiated divided by the number of cycles with embryo transfers Miscarriage rate: Number of miscarriages divided by the number of cycles with embryo transfers Multiple rate: Number cycles with twins or triplets divided by the number of cycles with embryo transfers Miscarriage rate per clinical pregnancy: Number of miscarriages divided by the number of cycles with clinical pregnancy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Medical Device: INVOcell Culture Device | Other | Device: INVOcell Culture Device5 day oocyte incubation using INVOcell Culture Device within the vaginal cavity. |
| Medical Device: IVF Incubator | Active comparator | Device: IVF Incubation5 day oocyte incubation using traditional IVF incubation. |
Who may qualify
- Ages
- 18 to 38 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (22 listed)
- Couples who will participate to the study will be pre selected for the following major indications:
- Tubal factor
- Endometriosis (type I to II)
- Ovulatory dysfunction (slight)
- Multiple female factors (<2)
Key exclusion criteria (29 listed)
- Inability to read and speak English fluently
- A history of recurrent vaginitis
- A history of toxic shock syndrome
- Known allergies to plastic, human serum proteins or gentamicin
- Had pelvic surgery within the past 8 weeks, excluding diagnostic laparoscopy
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 Culture DeviceAlso: INVOcell, INVOcell Culture DeviceINVOcell is a vaginal culture device | Device | Medical Device: INVOcell Culture Device |
| IVF IncubationIVF Incubator | Device | Medical Device: IVF Incubator |
Primary outcome
Blastocyst Quality
Time frame: Measures assessed following 5 days incubation, approximately 17 days following randomization
Blastocyst generation rate: number of day 5 embryos of "good quality" defined as 2BB or greater (expansion of embryo 2,3,4,5 or 6 and inner cell mass and outer cell mass grades of A or B) or higher using the Gardner Grading System divided by the number of eggs incubated
7 secondary outcomes
Patient Acceptability
Time frame: Measures assessed at first followup visit following embryo transfer, approximately 9 weeks post randomization
Live Birth Rate
Time frame: Measures assessed 9 months post embryo transfer, approximately 9 months and two weeks following randomization
Clinical Pregnancy Rate
Time frame: Measures assessed approximately 16 days following embryo transfer, approximately 4 weeks following randomization.
Fertilization Rate
Time frame: Measures assessed following 5 days post incubation, approximately 2 and 1/2 weeks post randomization.
Embryo Transfer Rate
Time frame: Measures assessed following 5 days incubation, approximately 2 and 1/2 weeks following randomization.
Miscarriage Rate
Time frame: Measures assessed following embryo transfer and a maximum of 9 months gestation.
Multiple Rate
Time frame: Measures assessed 9 months after the last subject received an embryo transfer, once all live birth data is known for each embryo.
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 20 Jan 2016.
- Background: PubMed 3350160Ranoux C, Aubriot FX, Dubuisson JB, Cardone V, Foulot H, Poirot C, Chevallier O. A new in vitro fertilization technique: intravaginal culture. Fertil Steril. 1988 Apr;49(4):654-7. doi: 10.1016/s0015-0282(16)59835-5.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing INVOcell Culture Device and IVF Incubation in people with Infertility, run by Invaron Pharmaceuticals Inc. 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 22 inclusion and 29 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 20 Jan 2016. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Blastocyst Quality (time frame: Measures assessed following 5 days incubation, approximately 17 days following randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02363426, which also lists 1 linked publication.
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 20 Jan 2016.