Randomized Controlled Trial Comparing Intra-vaginal Culture of Embryos Using INVOcell Device to In-vitro Culture of Embryos Using Minimal Stimulation Protocols
Phase: NA
Conditions: Infertility
Sponsor: University of California, San Francisco

 
 
 
Comparing Intra-vaginal Culture of Embryos to In-vitro Culture 
of Embryos with Minimal Stimulation 
 
NCT02802176 
 
Document Date: 6/27/2016 

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The enrollment target is 32 patients total. There are two groups and 16 patients will be 
randomized to each group: (1) intravaginal culture with INVOcell device (cases) versus (2) 
in-vitro fertiilzation and culture of embryos (controls).  However, we want to consent up to 
50 patients to account for any possible attrition (i.e. IVF cycle gets cancelled, lost to follow 
up, etc)
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As this is a pilot study, we chose to limit the number of participants enrolled. The goal is to 
enroll 32 participants, with 16 randomized to each group. Given the inclusion and exclusion 
criteria, we estimate that it will take us approximately 6 months to enroll the necessary 
number of patients. Participants will be enrolled on a rolling basis.
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aehYaj]?%kh][aAqCgo&
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afngdnaf_Y?ng[Yl]kaflC][gfk]flhjg[]kk
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8bYUV?iTUcSbYRUdXUCBCe?QdYBA#cdXQdgY??RUYAfB?fUTYAdXYccdeTi)?AS?eTU
?D9BKI?ED9H?JH?75
QAiBAUdXQdTQdQgY??RUSB??USdUTVbB@BbQRBed#U)W)CQdYUAdc'XUQ?dXiSBAdbB?c'SQbUWYfUbc'CbBfYTUbc'
QT@YAYcdbQdBbc'cdeTUAdc'CQbUAdc'VQ@Y?i@U@RUbc'UdS)5
Inclusion Criteria:
-Normal uterine cavity
-One or more years of infertility
-Normal male partner (or donor) semen analysis
4)3
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N9BKI?ED9H?JH?75
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Exclusion Criteria:
-Age < 18 or >37 years old
-AFC < 8
-Abnormal male partner (or donor) semen analysis
-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
-Drug of alcohol abuse (defined by >14 drinks/week)
-Prior history of IVF cycle where fertilization did not occur
-History of recurrent pregnancy loss
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At their first visit to the Center for Reproductive Health at the University of California at San Francisco, 
all eligible women will be identified by the clinician at the time of their initial infertility evaluation and 
approached about the study. At this time they can indicate participation or decline participation. They 
may consent at this visit or they will be given materials to take home and consider (patient information 
sheet and consent form).
If they have not done so already, when patients are ready to start their stimulation cycle, they will 
confirm whether or not they wish to participate in the study and sign the consent forms.
A study-specific research assistant or healthcare affiliate involved in the care of the patient will obtain 
informed consent at the first or second clinical visit. Or, if the prospective subject wishes, she may 
return at a later time to consent to study participation as long as this all occurs prior to oocyte retrieval 
day.
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The consenting research assistant or investigator will be responsible for determining whether subjects understand 
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obtaining consent) cannot answer, the question will be directed to research supervisor or Principal Investigator.
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As with all other patients at CRH, certified phlebotomists will perform all blood draws in order to minimize risk 
and discomfort associated with venipuncture. Safety monitoring procedures are in place for clinical phlebotomy 
procedures, and wherever adverse events are noted, the Principal Investigator will take appropriate action. No 
additional blood will be drawn for study patients besides what is routinely performed for infertility patients.
In order minimize risk to privacy and confidentiality, access to the research database will be limited to authorized 
personnel, including the principal investigator, co-investigators and research staff. Subject identities will not be 
revealed in any publication that may result from the proposed project. The master list for linking samples and 
clinical information to a particular subject will be considered high-security, and access will be limited to the 
principal investigator and co-investigators. Consent forms and PHI release forms will be kept in locked files. The 
confidentiality of all study-related records will be maintained in accordance with State and Federal Laws.
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Subjects who participate in the study are assigned a unique ID number that is maintained in a 
separate database only accessible to the Investigators and Research Staff. Any clinical data that is 
abstracted for the research database will not contain personally identifying variables (PHI). Data 
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will be continuously monitored by research staff. R
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There will also be a safety monitoring committee formed to oversee the study. The 
committee will meet monthly to review any safety concerns raised by the study.
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We will assemble a Data and Safety Monitoring Board, comprised of Mitchell Rosen 
(Reproductive Endocrinologist), Hakan Cakmak (Reproductive Endocrinologist) and 
Stephanie Jeniches, NP. The committee will meet monthly during the study and review any 
safety violations or concerns generated by patients completing the exercise protocols.
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brief survey