Clinical trial NCT02802176: Comparing Intra-vaginal Culture of Embryos to In-vitro Culture of Embryos With Minimal Stimulation
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Infertility
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2016-06-16
Enrollment: 39
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 37
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Arm 1: intra-vaginal culture using INVOcell device. Arm 2: Traditional In-Vitro Fertilization (IVF) culture in an embryology laboratory
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Implantation Rate
timeFrame: approximately 4 weeks following randomization. Clinically this is typically done around 6 weeks of gestational age
Secondary outcomes:
measure: Embryo Quality
timeFrame: measured after 3 days of incubation
measure: Fertilization Rate
timeFrame: measured after 3 days of incubation
measure: Clinical Pregnancy Rate
timeFrame: approximately 4 weeks following randomization. Clinically this is typically done around 6 weeks of gestational age
measure: Live Birth Rate
timeFrame: 9 months after embryo transfer
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California San Francisco - Center for Reproductive Health
state: California
Study officials:
affiliation: University of California, San Francisco
name: Marcelle Cedars, MD
role: PRINCIPAL_INVESTIGATOR
References: