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

Sponsor

University of California, San Francisco (Other)

Overall Status

Recruiting

CT.gov ID

NCT02802176

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Infertility	Device: INVOcell device Other: Traditional IVF	N/A

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 the Gardner grading system.
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 Design

Study Type:

Interventional

Anticipated Enrollment :

34 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jul 1, 2016

Anticipated Primary Completion Date :

Oct 1, 2022

Anticipated Study Completion Date :

Jan 1, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Implantation rate [approximately 4 weeks following randomization]
defined by number gestational sacs seen on early pregnancy 6-week ultrasound divided by number of embryos transferred

Secondary Outcome Measures

Embryo quality [measured after 3 days of incubation]
quality determined using Gardner grading system
Fertilization rate [measured after 3 days of incubation]
defined by the total number of fertilized oocytes divided by total number of mature oocytes retrieved
Clinical pregnancy rate [approximately 4 weeks following randomization]
which is defined by the number of fetal poles with heartbeat seen on 6-week ultrasound divided by the number of embryos transferred
Live birth rate [9 months after embryo transfer]
which is defined by the number of living babies delivered divided by the number of transfers

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 37 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of California San Francisco - Center for Reproductive Health	San Francisco	California	United States	94158

Sponsors and Collaborators

University of California, San Francisco

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.

Responsible Party:

University of California, San Francisco

ClinicalTrials.gov Identifier:

NCT02802176

Other Study ID Numbers:

IRB 166094

First Posted:

Jun 16, 2016

Last Update Posted:

Apr 11, 2022

Last Verified:

Apr 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Additional relevant MeSH terms:

Infertility

Study Results

No Results Posted as of Apr 11, 2022