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

Infertility Clinical Trial

Official title:

Randomized Controlled Trial Comparing Intra-vaginal Culture of Embryos Using INVOcell Device to In-vitro Culture of Embryos Using Minimal Stimulation Protocols

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02802176
• Other study ID #: IRB 166094
• Status: Terminated
• Phase: N/A
• Start date: October 2016
• Est. completion date: August 25, 2022

Study information

• Verified date: June 2023
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 39
• Est. completion date: August 25, 2022
• Est. primary completion date: April 20, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 37 Years

Eligibility

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

Related Conditions & MeSH terms

• Infertility

Intervention

Device:
• INVOcell device
intra-vaginal culture of embryos using INVOcell device

Other:
• Traditional IVF
traditional culture of embryos in-vitro

Locations

Country	Name	City	State
United States	University of California San Francisco - Center for Reproductive Health	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Embryo Quality	-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".	measured after 3 days of incubation
Secondary	Fertilization Rate	defined by the total number of fertilized oocytes divided by total number of mature oocytes retrieved	measured after 3 days of incubation
Secondary	Clinical Pregnancy Rate	which is defined by the number of fetal poles with heartbeat seen on early pregnancy ultrasound typically done at 6 weeks of gestational age divided by the number of embryos transferred	approximately 4 weeks following randomization. Clinically this is typically done around 6 weeks of gestational age
Secondary	Live Birth Rate	which is defined by the number of living babies delivered divided by the number of transfers	9 months after embryo transfer

External Links

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