Comparing Intra-vaginal Culture of Embryos to In-vitro Culture of Embryos With Minimal Stimulation
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|ClinicalTrials.gov Identifier: NCT02802176|
Recruitment Status : Recruiting
First Posted : June 16, 2016
Last Update Posted : January 13, 2021
|Condition or disease||Intervention/treatment||Phase|
|Infertility||Device: INVOcell device Other: Traditional IVF||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||34 participants|
|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 laboratory|
|Masking:||None (Open Label)|
|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 :||July 2016|
|Estimated Primary Completion Date :||June 1, 2021|
|Estimated Study Completion Date :||September 1, 2021|
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
- Implantation rate [ Time Frame: approximately 4 weeks following randomization ]defined by number gestational sacs seen on early pregnancy 6-week ultrasound divided by number of embryos transferred
- Embryo quality [ Time Frame: measured after 3 days of incubation ]quality determined using Gardner grading system
- Fertilization rate [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 9 months after embryo transfer ]which is defined by the number of living babies delivered divided by the number of transfers
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02802176
|Contact: Asima K Ahmad, MD, MPHemail@example.com|
|Contact: Marcelle Cedars, MD||4153537475|
|United States, California|
|University of California San Francisco - Center for Reproductive Health||Recruiting|
|San Francisco, California, United States, 94158|
|Contact: Asima K Ahmad, MD, MPH 415-353-7475 firstname.lastname@example.org|
|Contact: Nikolaus Lenhart 4153537475 email@example.com|
|Principal Investigator:||Marcelle Cedars, MD||University of California, San Francisco|