Comparing Intra-vaginal Culture of Embryos to In-vitro Culture of Embryos With Minimal Stimulation

NCT02802176 | Terminated Results DMC FDA Device

• 1 other identifier: IRB 166094
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate implantation rate with intra-vaginal culture (IVC) with the INVOcell device versus traditional In-Vitro Fertilization (IVF) while using minimal stimulation protocols

Conditions

Infertility

Outcome Measures

Primary Outcomes (1)

• Implantation Rate

  defined by number gestational sacs seen on early pregnancy ultrasound typically done at 6 weeks of gestational age divided by number of embryos transferred

  approximately 4 weeks following randomization. Clinically this is typically done around 6 weeks of gestational age

Secondary Outcomes (4)

• Embryo Quality

  measured after 3 days of incubation

• Fertilization Rate

  measured after 3 days of incubation

• Clinical Pregnancy Rate

  approximately 4 weeks following randomization. Clinically this is typically done around 6 weeks of gestational age

• Live Birth Rate

  9 months after embryo transfer

Study Arms (2)

Intra-vaginal culture - INVOcell device

EXPERIMENTAL

3 day intra-vaginal incubation using the INVOcell device

Device: INVOcell device

Traditional IVF culture

ACTIVE COMPARATOR

3 day traditional IVF incubation

Other: Traditional IVF

Interventions

INVOcell device DEVICE

intra-vaginal culture of embryos using INVOcell device

Intra-vaginal culture - INVOcell device

Traditional IVF OTHER

traditional culture of embryos in-vitro

Traditional IVF culture

Eligibility Criteria

• Age: 18 Years - 37 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Normal uterine cavity
• One or more years of infertility
• Normal male partner semen analysis

You may not qualify if:

• Age \<18 years old or \>37 years old
• Antral Follicle Count (AFC) \<8
• Abnormal male partner semen analysis or use of donor sperm
• Vaginal inflammation or genital (vaginal, uterine, tubal) infection
• Uncontrolled chronic disease (such as uncontrolled diabetes or hypertension)
• Uterine anatomic abnormalities
• Allergy to plastics or inability to use diaphragm retention device
• Untreated hydrosalpinx
• Current alcohol abuse (defined by \>14 drinks/week)
• Prior history of IVF cycle where fertilization did not occur
• History of recurrent pregnancy loss

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

University of California San Francisco - Center for Reproductive Health

San Francisco, California, 94158, United States

Location

Related Links

• INVOcell device
• University of California San Francisco Center for Reproductive Health

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Limitations and Caveats

Due to capacity limitations of the INVOcell device, participants in each arm were only allowed to fertilize up to 7 oocytes. Excess oocytes were frozen for all subjects for future use. This study also used a mild stimulation medication protocol to limit excessive eggs being produced under the assumption few participants would reach this imposed limit. At the time of study design, the device was only FDA approved for up to 3 day of embryo culturing. These factors may have limited some findings.

Results Point of Contact

• Title: Marcelle Cedars, MD, Director, Division of Reproductive Endocrinology
• Organization: University of California, San Francisco

Marcelle.Cedars@ucsf.edu

(415) 353-7475

Study Officials

• Marcelle Cedars, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Arm 1: intra-vaginal culture using INVOcell device. Arm 2: Traditional In-Vitro Fertilization (IVF) culture in an embryology laboratory

Study Record Dates

• First Submitted: June 12, 2016
• First Posted: June 16, 2016
• Study Start: October 1, 2016
• Primary Completion: April 20, 2022
• Study Completion: August 25, 2022
• Last Updated: July 12, 2023
• Results First Posted: July 12, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)