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

NCT ID: NCT02802176

Last Updated: 2023-07-12

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-31
• Study Completion Date: 2022-08-25

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

Detailed Description

This is a Phase IV, single center randomized controlled trial evaluating intra-vaginal culture (IVC) using INVOcell versus traditional In-Vitro Fertilization (IVF) using oral stimulation or minimal gonadotropin stimulation protocols. The pilot aims to includes 40 women who will be randomized to either the intra-vaginal culture group (N=20) using INVOcell or to the traditional IVF group (N=20).

Primary aim is implantation rate, which is defined by number gestational sacs seen on early pregnancy ultrasound divided by number of embryos transferred.

Secondary aims are:

• Embryo quality, which is measured by system similar to the Gardner grading system at cleavage stage. Reported quality will be converted to the simplified SART embryo scoring system which provides an overall categorical embryo grade of "Good", "Fair" or "Poor".
• Fertilization rate, which is defined by the total number of fertilized oocytes divided by total number of mature oocytes retrieved. This comparison will take place on day-3, as that is when the IVC embryos will be assessed.
• Clinical pregnancy rate, which is defined by the number of fetal poles with heartbeat seen on ultrasound divided by the number of embryos transferred.
• Live birth rate, which is defined by the number of living babies delivered divided by the number of transfers

Conditions

Infertility

Study Design

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

Study Groups

Intra-vaginal culture - INVOcell device

3 day intra-vaginal incubation using the INVOcell device

Group Type: EXPERIMENTAL

INVOcell device

Intervention Type: DEVICE

intra-vaginal culture of embryos using INVOcell device

Traditional IVF culture

3 day traditional IVF incubation

Group Type: ACTIVE_COMPARATOR

Traditional IVF

Intervention Type: OTHER

traditional culture of embryos in-vitro

Interventions

INVOcell device

intra-vaginal culture of embryos using INVOcell device

Intervention Type: DEVICE

Traditional IVF

traditional culture of embryos in-vitro

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 37 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marcelle Cedars, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

University of California San Francisco - Center for Reproductive Health

San Francisco, California, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Related Links

http://www.invobioscience.com/

INVOcell device

https://crh.ucsf.edu/

University of California San Francisco Center for Reproductive Health

Other Identifiers

IRB 166094

Identifier Type: -

Identifier Source: org_study_id