Not provided
Not provided
Not provided
Not provided
Not provided
Slow enrollment and completion of screening qualifiers.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
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:
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intra-vaginal culture - INVOcell device | Experimental | 3 day intra-vaginal incubation using the INVOcell device |
|
| Traditional IVF culture | Active Comparator | 3 day traditional IVF incubation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| INVOcell device | Device | intra-vaginal culture of embryos using INVOcell device |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | approximately 4 weeks following randomization. Clinically this is typically done around 6 weeks of gestational age |
| Measure | Description | Time Frame |
|---|---|---|
| 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 after 3 days of incubation |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Marcelle Cedars, MD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California San Francisco - Center for Reproductive Health | San Francisco | California | 94158 | United States |
Not provided
| Label | URL |
|---|---|
| INVOcell device | View source |
| University of California San Francisco Center for Reproductive Health | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
9 of 39 enrolled participants screen failed out of the study prior to randomization assignment. 6 never moved forward with starting clinical fertility treatment, 1 responded poorly to the minimal stimulation medication protocol that was part of the study design and couldn't proceed with the egg retrieval procedure, 1 was at risk for mild Ovarian Hyperstimulatory Syndrome and 1 voluntarily dropped out of the study prior to randomization due to financial and insurance coverage reasons.
Recruitment occurred between October 2016 to February 2022, apart from a two year period of the COVID-19 Pandemic. Potential subjects were recruited from patient populations of the UCSF Center for Reproductive Health, the Zuckerberg San Francisco General Hospital and the general public.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Traditional IVF Culture | 3 day traditional IVF incubation Traditional IVF: traditional culture of embryos in-vitro |
| FG001 | Intra-vaginal Culture - INVOcell Device | 3 day intra-vaginal incubation using the INVOcell device INVOcell device: intra-vaginal culture of embryos using INVOcell device |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Experimental: Intra-vaginal Culture - INVOcell Device | 3 day intra-vaginal incubation of embryos using INVOcell device |
| BG001 | Active Comparator: Traditional IVF Culture | 3 day traditional In Vitro Fertilization embryo incubation |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | 3 participants in the Traditional IVF culture arm and 2 participants in the intra-vaginal culture arm were excluded from analysis as they did not undergo embryo transfers. | Posted | Mean | Standard Deviation | percentage of embryo transfers | approximately 4 weeks following randomization. Clinically this is typically done around 6 weeks of gestational age |
|
4 weeks
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intra-vaginal Culture - INVOcell Device | 3 day intra-vaginal incubation using the INVOcell device INVOcell device: intra-vaginal culture of embryos using INVOcell device |
Not provided
Not provided
Due to capacity limitations of the INVOcell device, participants in each arm were only allowed to fertilize up to 7 oocytes. Excess oocytes were frozen for all subjects for future use. This study also used a mild stimulation medication protocol to limit excessive eggs being produced under the assumption few participants would reach this imposed limit. At the time of study design, the device was only FDA approved for up to 3 day of embryo culturing. These factors may have limited some findings.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Marcelle Cedars, MD, Director, Division of Reproductive Endocrinology | University of California, San Francisco | (415) 353-7475 | Marcelle.Cedars@ucsf.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 27, 2016 | May 1, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 12, 2022 | Apr 28, 2023 | ICF_001.pdf |
Not provided
| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
Not provided
Not provided
Arm 1: intra-vaginal culture using INVOcell device. Arm 2: Traditional In-Vitro Fertilization (IVF) culture in an embryology laboratory
Not provided
Not provided
Not provided
Not provided
| Traditional IVF | Other | traditional culture of embryos in-vitro |
|
| Fertilization Rate |
defined by the total number of fertilized oocytes divided by total number of mature oocytes retrieved |
| 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 | 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 | 9 months after embryo transfer |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
3 day traditional IVF incubation Traditional IVF: traditional culture of embryos in-vitro |
|
|
| Secondary | 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". | 1 participant from the intra-vaginal culture arm and 2 participants from the traditional IVF culture arm were excluded from the analysis due fertilization failures and no embryos on culture day 3 to grade. | Posted | Count of Units | Culture day 3 cleavage-stage embryos | measured after 3 days of incubation | Culture day 3 cleavage-stage embryos | Culture day 3 cleavage-stage embryos |
|
|
|
| Secondary | Fertilization Rate | defined by the total number of fertilized oocytes divided by total number of mature oocytes retrieved | Posted | Mean | Standard Deviation | percentage of oocytes fertilized | measured after 3 days of incubation |
|
|
|
| Secondary | 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 | 3 participants in the Traditional IVF culture arm and 2 participants in the intra-vaginal culture arm were excluded from analysis as they did not undergo embryo transfers. | Posted | Mean | Standard Deviation | percentage of embryo transfers | approximately 4 weeks following randomization. Clinically this is typically done around 6 weeks of gestational age |
|
|
|
| Secondary | Live Birth Rate | which is defined by the number of living babies delivered divided by the number of transfers | 3 participants in the Traditional IVF culture arm and 2 participants in the intra-vaginal culture arm were excluded from analysis as they did not undergo embryo transfers. | Posted | Mean | Standard Deviation | percentage of embryo transfers | 9 months after embryo transfer |
|
|
|
| 0 |
| 14 |
| 0 |
| 14 |
| 0 |
| 14 |
| EG001 | Traditional IVF Culture | 3 day traditional IVF incubation Traditional IVF: traditional culture of embryos in-vitro | 0 | 16 | 0 | 16 | 0 | 16 |
Not provided
Not provided
| "Poor" |
|