Vaginal Culture Using INVOcell Compared to Traditional IVF Incubation

This is an interventional treatment trial for Infertility focused on measuring intravaginal culture, in vitro fertilization, blastocyst, pregnancy Read More

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 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.

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
• 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.