NCT00699400

Oocyte Cryopreservation Registry (HOPE Registry)

A Phase IV, Prospective, Multicenter, Observational Oocyte Cryopreservation Registry

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 204 (actual)
• Sponsor: EMD Serono · Industry
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

Phase IV, prospective multicenter, observational Registry will track cycle outcomes for subjects who are thawing frozen oocytes for subsequent use through in vitro fertilization (IVF) and embryo transfer (ET)

Detailed description

Subjects will be enrolled at as many ART clinics that offer oocyte cryopreservation and are willing to participate in the Registry. Oocytes will be retrieved and cryopreserved from autologous or heterologous donors. When the subject decides she would like to get pregnant, oocytes will be thawed, fertilized and the resultant embryos will be transferred to the oocyte donor (for autologous use) or to another recipient (for heterologous use). The treatment regimen will be completed with births and well-baby follow-up of children at 12 months of age. Information on children will be submitted by their parents to the Investigators. Data collection for the Registry will be active for a maximum of five (5) years, including three (3) years of enrollment and two (2) additional years to complete the well-baby follow-up for all the children.

Conditions

• Oocyte Cryopreservation

Timeline

• Start date: 2008-06-01
• Primary completion: 2012-05-01
• Completion: 2012-07-01
• First posted: 2008-06-18
• Last updated: 2014-01-24
• Results posted: 2014-01-24

Locations

15 sites across 1 country: United States