NCT03021915

Single Center, Prospective Controlled Pilot Study of the OvaPrime Procedure

• Status: Suspended
• Phase: N/A
• Study type: Interventional
• Enrollment: 81 (actual)
• Sponsor: OvaScience, Inc. · Industry
• Sex: All
• Age: 21 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

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).

Conditions

• Primary Ovarian Insufficiency
• Poor Ovarian Response

Interventions

Type	Name	Description
OTHER	OvaPrime Treatment	The treatment is based on identified EggPC cells in the outer-most layer of the ovary. During OvaPrime, the EggPC cells are isolated from biopsy tissue obtained from the outer layer of the ovary. OvaScience separates the EggPC cells and these isolated cells are then returned to the IVF clinic - there is no culture or expansion of the EggPC cells during this process. Upon receipt of the autologous EggPC cells, the clinic initiates the process of reintroducing the cells into the follicular development zone of the woman's own ovary using a laparoscopic procedure. Once in the ovary, the EggPC cells have the opportunity to develop and mature into fertilizable eggs naturally or with controlled ovarian hyperstimulation (when stimulated by exogenous gonadotropins) using standard IVF protocols.

Timeline

• Start date: 2016-10-01
• Primary completion: 2022-06-01
• Completion: 2022-06-01
• First posted: 2017-01-16
• Last updated: 2018-11-28

Locations

1 site across 1 country: Canada