A Phase IV, Prospective, Multicenter, Observational Oocyte Cryopreservation Registry
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- EMD Serono
- Enrollment
- 204
- Locations
- 3
- Primary Endpoint
- Thawing Cycle Level Live Birth Rate
Study Overview
Brief 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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Must be in an ART program
- •Donor and recipients must be of reproductive age (18-50 years old, inclusive at the time of oocyte freezing and/or thawing) who intend to achieve a pregnancy by utilizing frozen thawed autologous or heterologous oocytes
- •Female and partner (if applicable) must voluntarily provide written informed consent/HIPAA authorization prior to any Registry-related data collection
- •Female and partner (if applicable) must be willing to provide a second written informed consent following each live birth prior to any Registry- related data collection on birth characteristics and twelve (12) month evaluation of offspring
- •Children born from women who take part in this registry from birth to 12 months (+/- 1 month) of age
Exclusion Criteria
- •Have clinically significant systemic disease
- •Have abnormal, undiagnosed gynecological bleeding
- •Have any contraindication to Controlled Ovarian Stimulation (COS) for ART and to gonadotropins to be used in ART
- •Also, in a rare situation, are undergoing ET with mixed embryos generated from fresh oocytes produced in the current cycle as well as frozen embryos generated from nonfrozen oocytes obtained in a previous ART cycle
- •Children born from women who do not take part in this Registry
- •Any offspring of woman who are not Registry subjects cannot take part in this registry
Outcomes
Primary Outcomes
Thawing Cycle Level Live Birth Rate
Time Frame: Birth of one or more live babies
Live birth rate per thawing cycle was calculated from the number of live births divided by the number of oocytes thawed less the number of embryos cryopreserved from thawed oocytes, averaged over all thawing cycles.
Secondary Outcomes
- Number of Oocytes Thawed(At start of thawing cycle)
- Oocyte Level Live Birth Rate(Birth of one or more live babies)
- Implantation Rate(At time of ultrasound after embryo transfer)
- Number of Miscarriages(Anytime after embryo transfer)
- Number of Live Babies(Birth of one or more live babies)
- Number of Oocytes Frozen(At cryopreservation)
- Oocyte Survival Rate(At time of fertilization)
- Number of Clinical Pregnancies(At time of ultrasound after embryo transfer)