Infertility
Conditions
Keywords
intravaginal culture, in vitro fertilization, blastocyst, pregnancy
Brief 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.
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
Interventions
DEVICEINVOcell Culture Device
INVOcell is a vaginal culture device
DEVICEIVF Incubation
IVF Incubator
Sponsors
Invaron Pharmaceuticals Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 38 Years
Healthy volunteers
Yes
Inclusion criteria
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) 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blastocyst Quality | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Live Birth Rate | Measures assessed 9 months post embryo transfer, approximately 9 months and two weeks following randomization | Live birth rate: number of cycles with a live birth divided by the number of cycles with embryo transfers. |
| Clinical Pregnancy Rate | Measures assessed approximately 16 days following embryo transfer, approximately 4 weeks following randomization. | Clinical pregnancy rate: number of cycles with fetal heartbeat at week 7 divided by the number of cycles with embryo transfers. |
| Fertilization Rate | Measures assessed following 5 days post incubation, approximately 2 and 1/2 weeks post randomization. | Fertilization rate: Number of embryos obtained after incubation divided by the number of oocytes placed in the device. |
| Patient Acceptability | Measures assessed at first followup visit following embryo transfer, approximately 9 weeks post randomization | Patient acceptability of INVOcell and intravaginal culture using a 12 point subjective and quantitative questionnaire. |
| Miscarriage Rate | Measures assessed following embryo transfer and a maximum of 9 months gestation. | Miscarriage rate: Number of miscarriages divided by the number of cycles with embryo transfers |
| Multiple Rate | Measures assessed 9 months after the last subject received an embryo transfer, once all live birth data is known for each embryo. | Multiple rate: Number cycles with twins or triplets divided by the number of cycles with embryo transfers |
| Embryo Transfer Rate | Measures assessed following 5 days incubation, approximately 2 and 1/2 weeks following randomization. | Embryo transfer rate: Number of cycles initiated divided by the number of cycles with embryo transfers |
Countries
United States
Outcome results
None listed