Primary Ovarian Insufficiency Clinical Trial
Official title:
Single Center, Prospective Controlled Pilot Study of the OvaPrime Procedure
This is a single center, prospective, controlled pilot safety research study. The primary
objective of this research study is to assess the safety with the use of the OvaPrime
procedure in women who are diagnosed with either primary ovarian insufficiency (POI) or poor
ovarian response (POR).
A maximum of ninety-five (95) subjects will be enrolled consisting of a minimum of thirty
(30) POI subjects and a minimum of fifty (50) POR to achieve the target sample size of 70
Modified Intent-to-Treat (mITT) subjects as the primary analysis population. Each subject
shall have one ovary exposed to the EggPC cells while the contralateral ovary is exposed to
the EggPC vehicle as a means to have each subject serve as their own control. Results between
the treatment and control ovary will be examined for relevant endpoints such as antral
follicle counts.
The duration of the research study is estimated at approximately 6 years total, for the
period spanning enrollment (estimated at approximately six months), eight months to the last
hyperstimulation and through completion of 5-year follow-up (main study protocol with one
year primary endpoint and LTFU sub-study which extends to 5 additional years).
n/a
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