CancerNCT02396095
Oocyte Cryopreservation Study (Egg Banking)
An observational study of Cancer, run by University of Pennsylvania at 1 site in United States.
Trial summary
Women of reproductive age who seek to freeze eggs for future pregnancy attempts may be eligible to participate in a study investigating pregnancies that result from frozen eggs. Read more about this study
- Who is it for?
- Ages 15 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cancer
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2008to Jul 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 45 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Study population: Penn Fertility Care
Who may be able to join
- age between 15 and 45
- desire oocyte cryopreservation or use of cryopreserved oocytes for the purposes of achieving pregnancy
- willingness to participate in study and provide informed consent
Who cannot join
- day 3 FSH over 20 mIU/ml, or Day 3 E2 over 100pg/ml
- ovarian cyst greater than 14mm at baseline ultrasound
- uncontrolled medical illness such as diabetes, hypertension, or cardiovascular disease
- current pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania, Reproductive Research Unit
Philadelphia, Pennsylvania, 19104-5509
About this study
Official title: Live Birthrate Following Oocyte Cryopreservation
Women of reproductive age who seek to freeze eggs for future pregnancy attempts may be eligible to participate in a study investigating pregnancies that result from frozen eggs.
Read the detailed description
Participants follow standard fertility protocols to stimulate the growth of multiple egg follicles. When the egg follicles are mature, the eggs will be removed under sedation, examined by an embryologist under a microscope and the mature eggs will be immediately frozen and kept frozen in tanks at Penn Fertility Care using the same methods of labeling and quality assurance currently in place for frozen embryos.
Eggs will be thawed in the future when the participant wishes to attempt pregnancy and fertilized by standard methods used during In Vitro Fertilization (IVF). Resulting embryos will be placed into the uterus by a procedure that will require approximately 15-30 minutes. The number of embryos to be transferred will be dictated by standard clinical practice. After embryo transfer, subjects will return for serum pregnancy tests at 14 days after the embryo transfer. For those who are not pregnant, there will be no further participation in the study. For those who do achieve pregnancy, trans-vaginal ultrasound will be performed at approximately 6 weeks gestation and weekly thereafter until 8 weeks gestation at which time, they will be referred to their general obstetrician for prenatal care. Participants will be asked to provide the study team with information about birthweight, height, length, gestational age at delivery, complications at delivery, and infant number. This information is routinely collected from patients undergoing conventional IVF in order to maintain quality assurance as recommended by the American Society of Reproductive Medicine. Information will also be collected from the participant's medical records including physical characteristics, medical and fertility history, semen analysis of the partner if appropriate, egg stimulation characteristics including medications, days of stimulation, number of egg follicles, number of mature and immature eggs retrieved, number of eggs frozen, number of eggs thawed, number of embryos, disposition of embryos, pregnancy test results, number of pregnancies that survived the first 12 weeks and prenatal screening tests.
- Conditions
- Cancer
- Keywords
- female, cancer
- Medical subject headings
- Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Live birthrate following transfer of embryos created from frozen eggs
Live birthrate following transfer of embryos created from frozen eggs in the setting of: Autologous oocyte cryopreservation in women without cancer vs.autologous oocyte cryopreservation in women with cancer.
Measured: 10 years
Secondary outcomes (1)
Oocyte survival rates
The number of oocytes surviving cryopreservation, storage, and thaw will be evaluated.
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2015 (estimated)
- Study startAug 2008
- Primary completionJul 2013
- Study completionJul 2013
Why it stopped: American Society of Reproductive Medicine guidelines, October 2012.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Clarisa Gracia, University of Pennsylvania
- Investigators
- Clarisa R Gracia, MD, MSCE, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02396095
- Sponsor's protocol ID
- 808392
- Status last verified
- Mar 2015
- First submitted
- 17 Mar 2015
- Last updated
- 24 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Live Birthrate Following Oocyte Cryopreservation
- ClinicalTrials.gov ID
- NCT02396095
- Acronym / sponsor ID
- 808392
- Conditions
- Cancer
- Keywords
- female, cancer
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: American Society of Reproductive Medicine guidelines, October 2012.
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- Aug 2008
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 24 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Women of reproductive age who seek to freeze eggs for future pregnancy attempts may be eligible to participate in a study investigating pregnancies that result from frozen eggs.
Detailed description
Participants follow standard fertility protocols to stimulate the growth of multiple egg follicles. When the egg follicles are mature, the eggs will be removed under sedation, examined by an embryologist under a microscope and the mature eggs will be immediately frozen and kept frozen in tanks at Penn Fertility Care using the same methods of labeling and quality assurance currently in place for frozen embryos.
Eggs will be thawed in the future when the participant wishes to attempt pregnancy and fertilized by standard methods used during In Vitro Fertilization (IVF). Resulting embryos will be placed into the uterus by a procedure that will require approximately 15-30 minutes. The number of embryos to be transferred will be dictated by standard clinical practice. After embryo transfer, subjects will return for serum pregnancy tests at 14 days after the embryo transfer. For those who are not pregnant, there will be no further participation in the study. For those who do achieve pregnancy, trans-vaginal ultrasound will be performed at approximately 6 weeks gestation and weekly thereafter until 8 weeks gestation at which time, they will be referred to their general obstetrician for prenatal care. Participants will be asked to provide the study team with information about birthweight, height, length, gestational age at delivery, complications at delivery, and infant number. This information is routinely collected from patients undergoing conventional IVF in order to maintain quality assurance as recommended by the American Society of Reproductive Medicine. Information will also be collected from the participant's medical records including physical characteristics, medical and fertility history, semen analysis of the partner if appropriate, egg stimulation characteristics including medications, days of stimulation, number of egg follicles, number of mature and immature eggs retrieved, number of eggs frozen, number of eggs thawed, number of embryos, disposition of embryos, pregnancy test results, number of pregnancies that survived the first 12 weeks and prenatal screening tests.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 15 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Penn Fertility Care
Key inclusion criteria (3 listed)
- age between 15 and 45
- desire oocyte cryopreservation or use of cryopreserved oocytes for the purposes of achieving pregnancy
- willingness to participate in study and provide informed consent
Key exclusion criteria (4 listed)
- day 3 FSH over 20 mIU/ml, or Day 3 E2 over 100pg/ml
- ovarian cyst greater than 14mm at baseline ultrasound
- uncontrolled medical illness such as diabetes, hypertension, or cardiovascular disease
- current pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Live birthrate following transfer of embryos created from frozen eggs
Time frame: 10 years
Live birthrate following transfer of embryos created from frozen eggs in the setting of: Autologous oocyte cryopreservation in women without cancer vs.autologous oocyte cryopreservation in women with cancer.
1 secondary outcome
Oocyte survival rates
Time frame: 10 years
Results and safety
The study was stopped early (reason given: American Society of Reproductive Medicine guidelines, October 2012.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2015.
- OncofertilityLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clarisa R Gracia, MD, MSCE principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: American Society of Reproductive Medicine guidelines, October 2012.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Live birthrate following transfer of embryos created from frozen eggs (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2015; AzTrials last refreshed its copy on 28 Oct 2026.