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Completed

NCT Number: NCT00699400

Oocyte Cryopreservation Registry (HOPE Registry)

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)

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Key information

Age range

18 year–50 year

Sex eligibility

Female

Study type

Observational

Primary location

Research Site, Fountain Valley, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

  1. Oocyte Level Live Birth Rate

    Time frame: Birth of one or more live babies

    Oocyte Level Live Birth Rate was calculated from the total number of live births divided by the total number of oocytes thawed less the total number of embryos cryopreserved from thawed oocytes

  2. Number of Live Babies

    Time frame: Birth of one or more live babies

  3. Number of Oocytes Frozen

    Time frame: At cryopreservation

  4. Number of Oocytes Thawed

    Time frame: At start of thawing cycle

  5. Oocyte Survival Rate

    Time frame: At time of fertilization

    Number of oocytes fertilized divided by number of oocytes thawed per thawing cycle

  6. Implantation Rate

    Time frame: At time of ultrasound after embryo transfer

    Implantation rate was calculated as the number of fetal sacs per transferred embryo averaged over all thawing cycles

  7. Number of Clinical Pregnancies

    Time frame: At time of ultrasound after embryo transfer

    Number of clinical pregnancies defined as the presence of one or more fetal sacs with a heartbeat.

  8. Number of Miscarriages

    Time frame: Anytime after embryo transfer

    Number of pregnancy outcomes reported as spontaneous abortions

Sponsors and collaborators

Lead sponsor

EMD Serono

Industry

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Jun 18, 2008
Registry last updated
Jan 24, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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