Trial Outcomes & Findings for Comparing Intra-vaginal Culture of Embryos to In-vitro Culture of Embryos With Minimal Stimulation (NCT NCT02802176)

Results Overview

defined by number gestational sacs seen on early pregnancy ultrasound typically done at 6 weeks of gestational age divided by number of embryos transferred

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

39 participants

Primary outcome timeframe

approximately 4 weeks following randomization. Clinically this is typically done around 6 weeks of gestational age

Results posted on

2023-07-12

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure	Traditional IVF Culture 3 day traditional IVF incubation Traditional IVF: traditional culture of embryos in-vitro	Intra-vaginal Culture - INVOcell Device 3 day intra-vaginal incubation using the INVOcell device INVOcell device: intra-vaginal culture of embryos using INVOcell device
Overall Study STARTED	16	14
Overall Study COMPLETED	16	14
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Experimental: Intra-vaginal Culture - INVOcell Device n=14 Participants 3 day intra-vaginal incubation of embryos using INVOcell device	Active Comparator: Traditional IVF Culture n=16 Participants 3 day traditional In Vitro Fertilization embryo incubation	Total n=30 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=14 Participants	0 Participants n=16 Participants	0 Participants n=30 Participants
Age, Categorical Between 18 and 65 years	14 Participants n=14 Participants	16 Participants n=16 Participants	30 Participants n=30 Participants
Age, Categorical >=65 years	0 Participants n=14 Participants	0 Participants n=16 Participants	0 Participants n=30 Participants
Sex: Female, Male Female	14 Participants n=14 Participants	16 Participants n=16 Participants	30 Participants n=30 Participants
Sex: Female, Male Male	0 Participants n=14 Participants	0 Participants n=16 Participants	0 Participants n=30 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	14 participants n=14 Participants	16 participants n=16 Participants	30 participants n=30 Participants

PRIMARY outcome

Timeframe: approximately 4 weeks following randomization. Clinically this is typically done around 6 weeks of gestational age

Population: 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.

defined by number gestational sacs seen on early pregnancy ultrasound typically done at 6 weeks of gestational age divided by number of embryos transferred

Outcome measures

Outcome measures
Measure	Intra-vaginal Culture - INVOcell Device n=12 Participants 3 day intra-vaginal incubation using the INVOcell device INVOcell device: intra-vaginal culture of embryos using INVOcell device	Traditional IVF Culture n=13 Participants 3 day traditional IVF incubation Traditional IVF: traditional culture of embryos in-vitro
Implantation Rate	12.50 percentage of embryo transfers Standard Deviation 0.2976	42.31 percentage of embryo transfers Standard Deviation 43.17

SECONDARY outcome

Timeframe: measured after 3 days of incubation

Population: 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.

-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".

Outcome measures

Outcome measures
Measure	Intra-vaginal Culture - INVOcell Device n=45 Culture day 3 cleavage-stage embryos 3 day intra-vaginal incubation using the INVOcell device INVOcell device: intra-vaginal culture of embryos using INVOcell device	Traditional IVF Culture n=58 Culture day 3 cleavage-stage embryos 3 day traditional IVF incubation Traditional IVF: traditional culture of embryos in-vitro
Embryo Quality "Good"	34 Culture day 3 cleavage-stage embryos	48 Culture day 3 cleavage-stage embryos
Embryo Quality "Fair"	4 Culture day 3 cleavage-stage embryos	4 Culture day 3 cleavage-stage embryos
Embryo Quality "Poor"	7 Culture day 3 cleavage-stage embryos	6 Culture day 3 cleavage-stage embryos

SECONDARY outcome

Timeframe: measured after 3 days of incubation

defined by the total number of fertilized oocytes divided by total number of mature oocytes retrieved

Outcome measures

Outcome measures
Measure	Intra-vaginal Culture - INVOcell Device n=14 Participants 3 day intra-vaginal incubation using the INVOcell device INVOcell device: intra-vaginal culture of embryos using INVOcell device	Traditional IVF Culture n=16 Participants 3 day traditional IVF incubation Traditional IVF: traditional culture of embryos in-vitro
Fertilization Rate	61.75 percentage of oocytes fertilized Standard Deviation 25.19	63.4 percentage of oocytes fertilized Standard Deviation 30.55

SECONDARY outcome

Timeframe: approximately 4 weeks following randomization. Clinically this is typically done around 6 weeks of gestational age

Population: 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.

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

Outcome measures

Outcome measures
Measure	Intra-vaginal Culture - INVOcell Device n=12 Participants 3 day intra-vaginal incubation using the INVOcell device INVOcell device: intra-vaginal culture of embryos using INVOcell device	Traditional IVF Culture n=13 Participants 3 day traditional IVF incubation Traditional IVF: traditional culture of embryos in-vitro
Clinical Pregnancy Rate	12.5 percentage of embryo transfers Standard Deviation 29.76	46.15 percentage of embryo transfers Standard Deviation 45.83

SECONDARY outcome

Timeframe: 9 months after embryo transfer

Population: 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.

which is defined by the number of living babies delivered divided by the number of transfers

Outcome measures

Outcome measures
Measure	Intra-vaginal Culture - INVOcell Device n=12 Participants 3 day intra-vaginal incubation using the INVOcell device INVOcell device: intra-vaginal culture of embryos using INVOcell device	Traditional IVF Culture n=13 Participants 3 day traditional IVF incubation Traditional IVF: traditional culture of embryos in-vitro
Live Birth Rate	12.5 percentage of embryo transfers Standard Deviation 29.76	38.46 percentage of embryo transfers Standard Deviation 44.52

Adverse Events

Intra-vaginal Culture - INVOcell Device

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Traditional IVF Culture

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Marcelle Cedars, MD, Director, Division of Reproductive Endocrinology

University of California, San Francisco

Phone: (415) 353-7475

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place