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

Not Applicable

Terminated

• Conditions: Infertility
• Interventions: Device: INVOcell device; Other: Traditional IVF

• Registration Number: NCT02802176
• Lead Sponsor: University of California, San Francisco

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

Study Timeline

• Study First Submitted: 2016-06-12
• Study First Submitted QC: 2016-06-12
• Study First Posted: 2016-06-16
• Study Start: 2016-10
• Primary Completion: 2022-04-20
• Study Completion: 2022-08-25
• Results First Submitted: 2023-05-01
• Status Verified: 2023-06
• Results First Submitted QC: 2023-06-21
• Last Update Submitted: 2023-06-21
• Results First Posted: 2023-07-12
• Last Update Posted: 2023-07-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 39

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intra-vaginal culture - INVOcell device	INVOcell device	3 day intra-vaginal incubation using the INVOcell device
Traditional IVF culture	Traditional IVF	3 day traditional IVF incubation

Primary Outcome Measures

Name	Time	Method
Implantation Rate	approximately 4 weeks following randomization. Clinically this is typically done around 6 weeks of gestational age	defined by number gestational sacs seen on early pregnancy ultrasound typically done at 6 weeks of gestational age divided by number of embryos transferred

Secondary Outcome Measures

Name	Time	Method
Embryo Quality	measured after 3 days of incubation	-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	measured after 3 days of incubation	defined by the total number of fertilized oocytes divided by total number of mature oocytes retrieved
Live Birth Rate	9 months after embryo transfer	which is defined by the number of living babies delivered divided by the number of transfers
Clinical Pregnancy Rate	approximately 4 weeks following randomization. Clinically this is typically done around 6 weeks of gestational age	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

Trial Locations

Locations (1)

University of California San Francisco - Center for Reproductive Health; 🇺🇸 San Francisco, California, United States