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
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Blastocyst Quality
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 38 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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/
排除标准
- •(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 >
- •Exclusion Criteria:
- •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
- •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
- •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.
研究组 & 干预措施
Medical Device: INVOcell Culture Device
5 day oocyte incubation using INVOcell Culture Device within the vaginal cavity.
干预措施: INVOcell Culture Device (Device)
Medical Device: IVF Incubator
5 day oocyte incubation using traditional IVF incubation.
干预措施: IVF Incubation (Device)
结局指标
主要结局
Blastocyst Quality
时间窗: 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
次要结局
- Clinical Pregnancy Rate(Measures assessed approximately 16 days following embryo transfer, approximately 4 weeks following randomization.)
- Patient Acceptability(Measures assessed at first followup visit following embryo transfer, approximately 9 weeks post randomization)
- Live Birth Rate(Measures assessed 9 months post embryo transfer, approximately 9 months and two weeks following randomization)
- Embryo Transfer Rate(Measures assessed following 5 days incubation, approximately 2 and 1/2 weeks following randomization.)
- Multiple Rate(Measures assessed 9 months after the last subject received an embryo transfer, once all live birth data is known for each embryo.)
- Fertilization Rate(Measures assessed following 5 days post incubation, approximately 2 and 1/2 weeks post randomization.)
- Miscarriage Rate(Measures assessed following embryo transfer and a maximum of 9 months gestation.)