Vaginal Culture Using INVOcell Compared to Traditional IVF Incubation

NCT02363426 | Completed Phase 3

• 1 other identifier: CP-006
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Infertility

Keywords

intravaginal culture; in vitro fertilization; blastocyst; pregnancy

Outcome Measures

Primary Outcomes (1)

• Blastocyst Quality

  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

  Measures assessed following 5 days incubation, approximately 17 days following randomization

Secondary Outcomes (7)

• 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

• Clinical Pregnancy Rate

  Measures assessed approximately 16 days following embryo transfer, approximately 4 weeks following randomization.

• Fertilization Rate

  Measures assessed following 5 days post incubation, approximately 2 and 1/2 weeks post randomization.

• Embryo Transfer Rate

  Measures assessed following 5 days incubation, approximately 2 and 1/2 weeks following randomization.

Study Arms (2)

Medical Device: INVOcell Culture Device

OTHER

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

Device: INVOcell Culture Device

Medical Device: IVF Incubator

ACTIVE COMPARATOR

5 day oocyte incubation using traditional IVF incubation.

Device: IVF Incubation

Interventions

INVOcell Culture Device DEVICE

INVOcell is a vaginal culture device

Also known as: INVOcell, INVOcell Culture Device

Medical Device: INVOcell Culture Device

IVF Incubation DEVICE

IVF Incubator

Medical Device: IVF Incubator

Eligibility Criteria

• Age: 18 Years - 38 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Invaron Pharmaceuticals Inc.: lead

Study Sites (1)

C.A.R.E.

Beford, Texas, United States

Location

Related Publications (1)

• 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.

  PMID: 3350160 BACKGROUND

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2015
• First Posted: February 16, 2015
• Study Start: January 1, 2013
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: January 20, 2016

Record last verified: 2016-01

Locations

US (1)