Oocyte Cryopreservation Registry (HOPE Registry) - Full Text View

Sponsor:	EMD Serono
Information provided by (Responsible Party):	EMD Serono
ClinicalTrials.gov Identifier:	NCT00699400

Purpose

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)

Condition
Oocyte Cryopreservation

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	A Phase IV, Prospective, Multicenter, Observational Oocyte Cryopreservation Registry

Further study details as provided by EMD Serono:

Primary Outcome Measures:

Prospectively register and track the outcomes of cycles with frozen-thawed oocytes that are fertilized and transferred in subjects [ Time Frame: Multiple timepoints ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Identify factors associated with successful cycle outcomes and to monitor the child's health and development immediately after birth and at twelve (12) months of age, utilizing standard medical practices. [ Time Frame: Multiple timepoints ] [ Designated as safety issue: No ]

Estimated Enrollment:	400
Study Start Date:	June 2008
Estimated Study Completion Date:	September 2012
Estimated Primary Completion Date:	August 2012 (Final data collection date for primary outcome measure)

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.

Eligibility

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

Women of reproductive age who, in order to achieve a pregnancy, will have embryos created from thawed autologously or heterologously implanted oocytes that were either:

cryopreserved at the time of or following the Registry's launch, or
cryopreserved prior to the Registry's launch, but will undergo thaw/fertilization/transfer procedures while the subject is enrolled in the Registry.

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00699400

Show 26 Study Locations

Sponsors and Collaborators

EMD Serono

Investigators

Study Director:

Mary Mahony, PhD, HCLD (AAB)

EMD Serono, Inc.

More Information

No publications provided

Responsible Party:	EMD Serono
ClinicalTrials.gov Identifier:	NCT00699400 History of Changes
Other Study ID Numbers:	28599
Study First Received:	June 13, 2008
Last Updated:	January 10, 2012
Health Authority:	United States: Institutional Review Board

ClinicalTrials.gov processed this record on February 07, 2012