Fertility PreservationNCT01448460
Oocyte Vitrification for In Vitro Fertilization (IVF) Patients and Women With Fertility Threatening Conditions
An observational study of Fertility Preservation, run by University of Louisville.
Trial summary
Vitrification is a method of cryopreserving tissue for future use. It is widely used to preserve extra, good quality embryos generated from infertility treatments. It is becoming popular for the preservation of oocytes (eggs) as well, but is still considered investigational in this respect. Read more about this study
- Who is it for?
- Ages 14 to 42 years, women only
- Conditions the study is for
- Fertility Preservation
- How many people
- 8 participants
- Where
- No sites listed yet
- Study dates
- Sep 2009to Jan 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 14 to 42 years
- Women only
- No healthy volunteers
- Child, Adult
Study population: IVF patients who desire to have extra eggs, in excess of what is needed for their IVF cycle, or subjects requesting fertility preservation due to fertility threatening conditions such as cancer, advanced age or other.
Who may be able to join
- Women between the ages of 18 and 37 and who require IVF for a successful pregnancy will be approached to consent for the study,. They must also have a cycle day 3 FSH < 10 mIU/ml, estradiol < 70 pg/ml and a baseline follicle count > 10. The BMI must be between 20 and 32kg/m2. If they do consent, eggs will only be vitrified if 13 or more mature metaphase II oocytes are collected.
- Women between the ages of 14 and 42 who are seeking treatment for fertility preservation. In addition they must also meet the following criteria.
- Patient is willing and able to delay any relevant therapy for up to 40 days.
- Have functioning ovaries as determined by blood / ultrasound testing.
- Patient is willing to undergo infectious disease testing for HIV, hepatitis B and C, syphilis, gonorrhea and Chlamydia.
- The patient must have clearance from their oncologist or medical specialist, if any, to undergo ovarian stimulation and transvaginal oocyte retrieval.
- The patient must not have a past history of blood clots in the veins or in the lungs.
- The patient must be willing to undergo transvaginal, internal ultrasound examination and pelvic examination.
Who cannot join
- Patients with a cycle day 3 FSH > 10 mIU/ml, cycle day 3 estradiol > 70 pg/ml and a baseline follicle count < 10 will be excluded.
- Patients with a BMI <20 and >32 will be excluded.
- Patients who are not willing or are unable to meet the above mentioned eligibility requirments.
- Patients with expected low ovarian reserve [evaluated on day 3 by an antral follicle count of <3 follicles at 2-5 mm diameter and/or an increased concentration of follicle stimulating hormone (FSH) >15 IU [15] on cycle day 3 ].
- Patients with possible poor quality of oocytes, based on medical history including previous exposure to chemotherapeutics or radiation.
About this study
Official title: Oocyte Vitrification for IVF Patients and Women With Fertility Threatening Conditions
Vitrification is a method of cryopreserving tissue for future use. It is widely used to preserve extra, good quality embryos generated from infertility treatments. It is becoming popular for the preservation of oocytes (eggs) as well, but is still considered investigational in this respect. The purpose of this study is to provide egg freezing for patients desiring fertility preservation. Although commonly used in clinics around the world, it should be offered as an IRB approved study procedure until it is no longer considered investigational by the American Society of Reproductive Medicine.
- Conditions
- Fertility Preservation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Fertility Patients | IVF patients with extra eggs or other subjects who desire egg vitrification for fertility preservation |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2011 (estimated)
- Study startSep 2009
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fertility PreservationStudies of the same condition, open and under way.
- More trials run by University of LouisvilleThe 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
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Louisville
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Greg L. Christensen, University of Louisville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01448460
- Sponsor's protocol ID
- 09.356
- Status last verified
- Jan 2013
- First submitted
- 5 Oct 2011
- Last updated
- 24 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oocyte Vitrification for IVF Patients and Women With Fertility Threatening Conditions
- ClinicalTrials.gov ID
- NCT01448460
- Acronym / sponsor ID
- 09.356
- Conditions
- Fertility Preservation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of LouisvilleUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 7 Oct 2011 (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.
Vitrification is a method of cryopreserving tissue for future use. It is widely used to preserve extra, good quality embryos generated from infertility treatments. It is becoming popular for the preservation of oocytes (eggs) as well, but is still considered investigational in this respect. The purpose of this study is to provide egg freezing for patients desiring fertility preservation. Although commonly used in clinics around the world, it should be offered as an IRB approved study procedure until it is no longer considered investigational by the American Society of Reproductive Medicine.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fertility Patients | – | –IVF patients with extra eggs or other subjects who desire egg vitrification for fertility preservation |
Who may qualify
- Ages
- 14 to 42 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- IVF patients who desire to have extra eggs, in excess of what is needed for their IVF cycle, or subjects requesting fertility preservation due to fertility threatening conditions such as cancer, advanced age or other.
Key inclusion criteria (8 listed)
- Women between the ages of 18 and 37 and who require IVF for a successful pregnancy will be approached to consent for the study,. They must also have a cycle day 3 FSH < 10 mIU/ml, estradiol < 70 pg/ml and a baseline follicle count > 10. The BMI must be between 20 and 32kg/m2. If they do consent, eggs will only be vitrified if 13 or more mature metaphase II oocytes are collected.
- Women between the ages of 14 and 42 who are seeking treatment for fertility preservation. In addition they must also meet the following criteria.
- Patient is willing and able to delay any relevant therapy for up to 40 days.
- Have functioning ovaries as determined by blood / ultrasound testing.
- Patient is willing to undergo infectious disease testing for HIV, hepatitis B and C, syphilis, gonorrhea and Chlamydia.
Key exclusion criteria (5 listed)
- Patients with a cycle day 3 FSH > 10 mIU/ml, cycle day 3 estradiol > 70 pg/ml and a baseline follicle count < 10 will be excluded.
- Patients with a BMI <20 and >32 will be excluded.
- Patients who are not willing or are unable to meet the above mentioned eligibility requirments.
- Patients with expected low ovarian reserve [evaluated on day 3 by an antral follicle count of <3 follicles at 2-5 mm diameter and/or an increased concentration of follicle stimulating hormone (FSH) >15 IU [15] on cycle day 3 ].
- Patients with possible poor quality of oocytes, based on medical history including previous exposure to chemotherapeutics or radiation.
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
Not reported in the source record.
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 24 Jan 2013.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Fertility Preservation, run by University of Louisville.
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 8 inclusion and 5 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 24 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
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.
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 Jan 2013; AzTrials last refreshed its copy on 8 Nov 2026.