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

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

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

Study Overview

• Status: Terminated
• Conditions: Infertility
• Intervention / Treatment: Device: INVOcell device; Other: Traditional IVF

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

• Study Type: Interventional
• Enrollment (Actual): 39
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94158
      • University of California San Francisco - Center for Reproductive Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 37 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intra-vaginal culture - INVOcell device; 3 day intra-vaginal incubation using the INVOcell device	Device: INVOcell device; intra-vaginal culture of embryos using INVOcell device
Active Comparator: Traditional IVF culture; 3 day traditional IVF incubation	Other: Traditional IVF; traditional culture of embryos in-vitro

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Fertilization Rate	defined by the total number of fertilized oocytes divided by total number of mature oocytes retrieved	measured after 3 days of incubation
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
Live Birth Rate	which is defined by the number of living babies delivered divided by the number of transfers	9 months after embryo transfer

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Investigators: Principal Investigator: Marcelle Cedars, MD, University of California, San Francisco

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2016
• Primary Completion (Actual): April 20, 2022
• Study Completion (Actual): August 25, 2022

Study Registration Dates

• First Submitted: June 12, 2016
• First Submitted That Met QC Criteria: June 12, 2016
• First Posted (Estimated): June 16, 2016

Study Record Updates

• Last Update Posted (Actual): July 12, 2023
• Last Update Submitted That Met QC Criteria: June 21, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Infertility
• Other Study ID Numbers: IRB 166094

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes