Vaginal Culture Using INVOcell Compared to Traditional IVF Incubation

Completed · Phase 3

Conditions studied: Infertility

In brief

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.

Key facts

Study ID

NCT02363426

Run by

Invaron Pharmaceuticals Inc.

People needed

40

Starts

2013-01-01

Expected to finish

2016-01-01

Last updated by the study team

2016-01-20

Who can join

Age: 18 and older, up to 38. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• C.A.R.E. — Beford, Texas, United States

Full record on ClinicalTrials.gov

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