Vaginal Culture Using INVOcell Compared to Traditional IVF Incubation

NCT ID: NCT02363426

Last Updated: 2016-01-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2016-01-31

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

Conditions

Infertility

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Medical Device: INVOcell Culture Device

5 day oocyte incubation using INVOcell Culture Device within the vaginal cavity.

Group Type: OTHER

INVOcell Culture Device

Intervention Type: DEVICE

INVOcell is a vaginal culture device

Medical Device: IVF Incubator

5 day oocyte incubation using traditional IVF incubation.

Group Type: ACTIVE_COMPARATOR

IVF Incubation

Intervention Type: DEVICE

IVF Incubator

Interventions

INVOcell Culture Device

INVOcell is a vaginal culture device

Intervention Type: DEVICE

IVF Incubation

IVF Incubator

Intervention Type: DEVICE

Other Intervention Names

INVOcell, INVOcell Culture Device

Eligibility Criteria

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)

Exclusion Criteria

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.

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 38 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Invaron Pharmaceuticals Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

C.A.R.E.

Beford, Texas, United States

Countries

United States

References

Ranoux C, Aubriot FX, Dubuisson JB, Cardone V, Foulot H, Poirot C, Chevallier O. A new in vitro fertilization technique: intravaginal culture. Fertil Steril. 1988 Apr;49(4):654-7. doi: 10.1016/s0015-0282(16)59835-5.

Reference Type: BACKGROUND

PMID: 3350160 (View on PubMed)

Other Identifiers

CP-006

Identifier Type: -

Identifier Source: org_study_id