InfertilityNCT00839839
Egg Freezing Pilot Study
A study testing Oocyte Vitrification in people with Infertility and Egg Freezing, run by University Reproductive Associates at 1 site in United States.
Trial summary
University Reproductive Associates is conducting a pilot study to study the technique of egg freezing. Your participation in this study will provide us with important information to allow us to offer this technology for women wishing to freeze their eggs before cancer treatments. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Infertility, Egg Freezing
- What is being tested?
- Oocyte Vitrification
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2009to Feb 2011
- Phase
- Interventional
- 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 18 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 10 women between the ages of 18-35 inclusive at time of signing Informed Consent Form.
- In good general health off of current medications which may confound response to study medications.
- Desire to seek pregnancy actively during the study period by IVF-ICSI.
- A normal uterine cavity must have been confirmed by either hydrosonogram or hysteroscopy within two years of entering the study.
- Ability to use the required medications.
- Day 3 FSH level < 12 IU/ml
Who cannot join
- Current pregnancy
- Patients with significant anemia (Hemoglobin < 10 mg/dL).
- Patients enrolled simultaneously into other investigative studies that would interfere with this research study.
Trial locations and contacts
1 site in 1 country.
United States1 site
University Reproductive Associates
Hasbrouck Heights, New Jersey, 07604
About this study
Official title: Oocyte Cryopreservation in Assisted Reproduction
University Reproductive Associates is conducting a pilot study to study the technique of egg freezing. Your participation in this study will provide us with important information to allow us to offer this technology for women wishing to freeze their eggs before cancer treatments. Your participation will include a standard IVF cycle with your eggs being frozen for a brief period of time and then transferred back to you as usual. You will receive a significant reduction in your IVF cycle cost.
- Conditions
- Infertility, Egg Freezing
- Being tested
- Oocyte Vitrification
- Keywords
- infertility, egg freezing, fertility preservation
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oocyte VitrificationProcedure or surgery
All oocytes retrieved will be vitrified (rapidly frozen) after egg retrieval. The oocytes will then be warmed on the same day and fertilized per standard IVF-ICSI. Resulting embryos will be transferred back to the patient as per protocol.
| Study group | Role | What they receive |
|---|---|---|
| Oocyte Vitrification | Experimental | Not described Receives: Procedure: Oocyte Vitrification |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Biochemical Pregnancy
Measured: 1 year
Secondary outcomes (4)
Recovery of viable oocytes
Measured: 1 year
incidence of fertilization
Measured: one year
embryo development (how many fertilized eggs undergo development to a more advanced stage)
Measured: 1 year
clinical pregnancy (fetal pole visible on transvaginal ultrasound) per cycle
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2009 (estimated)
- Study startFeb 2009
- Primary completionJun 2010
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Reproductive Associates
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter McGovern, MD, University Reproductive Associates
- Investigators
- Peter G. McGovern, MD, Principal investigator, UMDNJ-NJMS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00839839
- Sponsor's protocol ID
- IRB 0120080226
- Status last verified
- Dec 2015
- First submitted
- 9 Feb 2009
- Last updated
- 3 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oocyte Cryopreservation in Assisted Reproduction
- ClinicalTrials.gov ID
- NCT00839839
- Acronym / sponsor ID
- IRB 0120080226
- Conditions
- Infertility, Egg Freezing
- Keywords
- infertility, egg freezing, fertility preservation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University Reproductive AssociatesUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Jun 2010 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 10 Feb 2009 (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.
University Reproductive Associates is conducting a pilot study to study the technique of egg freezing. Your participation in this study will provide us with important information to allow us to offer this technology for women wishing to freeze their eggs before cancer treatments. Your participation will include a standard IVF cycle with your eggs being frozen for a brief period of time and then transferred back to you as usual. You will receive a significant reduction in your IVF cycle cost.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Oocyte Vitrification | Experimental | Procedure: Oocyte Vitrification |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 10 women between the ages of 18-35 inclusive at time of signing Informed Consent Form.
- In good general health off of current medications which may confound response to study medications.
- Desire to seek pregnancy actively during the study period by IVF-ICSI.
- A normal uterine cavity must have been confirmed by either hydrosonogram or hysteroscopy within two years of entering the study.
- Ability to use the required medications.
Key exclusion criteria (3 listed)
- Current pregnancy
- Patients with significant anemia (Hemoglobin < 10 mg/dL).
- Patients enrolled simultaneously into other investigative studies that would interfere with this research study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oocyte VitrificationAll oocytes retrieved will be vitrified (rapidly frozen) after egg retrieval. The oocytes will then be warmed on the same day and fertilized per standard IVF-ICSI. Resulting embryos will be transferred back to the patient as per protocol. | Procedure or surgery | Oocyte Vitrification |
Primary outcome
Incidence of Biochemical Pregnancy
Time frame: 1 year
4 secondary outcomes
Recovery of viable oocytes
Time frame: 1 year
incidence of fertilization
Time frame: one year
embryo development (how many fertilized eggs undergo development to a more advanced stage)
Time frame: 1 year
clinical pregnancy (fetal pole visible on transvaginal ultrasound) per cycle
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2015.
- Related InfoLink 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.
Peter G. McGovern, MD principal investigator
UMDNJ-NJMS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oocyte Vitrification in people with Infertility and Egg Freezing, run by University Reproductive Associates 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 6 inclusion and 3 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: finished, as of the sponsor's last update on 3 Dec 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence of Biochemical Pregnancy (time frame: 1 year). 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 3 Dec 2015.