FertilityEarly Phase 1NCT01422395
Effect of Oocyte Vitrification on Fertilization Rate, Embryo Quality and Development
A Early Phase 1 study testing Freezing in people with Fertility, run by Main Line Fertility Center at 1 site in United States.
Trial summary
Indications for oocyte (egg) vitrification (fast freezing) include the preservation of reproductive competence of young cancer patients who need chemotherapy, pelvic radiation, or surgical removal of ovaries for treatment. Read more about this study
- Who is it for?
- Ages 21 to 37 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fertility
- What is being tested?
- Freezing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2011to May 2013
- Phase
- Early Phase 1
- 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 21 to 37 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy women ages 21-37 (inclusive)undergoing IVF in an attempt to achieve pregnancy
- Day 2-4 FSH < 10 IU/ml, LH <12 IU/ml, and E2 <50 pg/ml
- Antimullerian Hormone (AMH) >1.5
- Between 5 and 20 basal antral follicles on day 2-4 of the menstrual cycle
- BMI >18 and <32
Who cannot join
- Smokers
- Polycystic Ovarian Syndrome (PCO)
Trial locations and contacts
1 site in 1 country.
United States1 site
Main Line Fertility Center
Bryn Mawr, Pennsylvania, 19010
About this study
Official title: A Study to Compare Vitrified/Warmed Oocytes vs. Fresh Sibling Oocytes Collected Following Controlled Ovarian Stimulation Using Follistim AQ and Ganirelix Acetate on Fertilization Rates, Zygote Quality, Embryo Quality and Embryo Development
Indications for oocyte (egg) vitrification (fast freezing) include the preservation of reproductive competence of young cancer patients who need chemotherapy, pelvic radiation, or surgical removal of ovaries for treatment. Furthermore, the ability to freeze oocytes allows patients to reduce the number of embryos frozen, thereby circumventing the moral and ethical dilemmas of having left-over embryos in cryostorage. In addition, oocyte cryopreservation could allow women to delay childbearing if they want or need to. Until recently, conventional cryopreservation protocols have remained too inefficient for practical application in an infertility center. Very little is known about the effects of vitrification on oocytes and subsequent embryo development, especially using the sibling model (group of oocytes from the same cohort of ovarian follicles within patient). The purpose of this study is to examine the effect of oocyte vitrification on fertilization rates, embryo quality and development.
- Conditions
- Fertility
- Being tested
- Freezing
- Keywords
- Vitrification, Egg Freezing, Oocyte Cryopreservation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FreezingProcedure or surgery
Vitrification
| Study group | Role | What they receive |
|---|---|---|
| freezing | Experimental | Not described Receives: Procedure: Freezing |
| No freezing | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
fertilization rate
Measured: 18 hours after insemination
Embryo Quality
Measured: day 3 and day 5
Embryo Development
Measured: Day 3 and day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2011 (estimated)
- Study startAug 2011
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FertilityStudies 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
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Main Line Fertility Center
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Glassner J Michael, M.D., Principal investigator, Main Line Fertility CenterSharon H. Anderson, Ph.D, Study director, Main Line Fertility Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01422395
- Sponsor's protocol ID
- MLFC-001
- Status last verified
- Jun 2014
- First submitted
- 22 Aug 2011
- Last updated
- 4 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Compare Vitrified/Warmed Oocytes vs. Fresh Sibling Oocytes Collected Following Controlled Ovarian Stimulation Using Follistim AQ and Ganirelix Acetate on Fertilization Rates, Zygote Quality, Embryo Quality and Embryo Development
- ClinicalTrials.gov ID
- NCT01422395
- Acronym / sponsor ID
- MLFC-001
- Conditions
- Fertility
- Keywords
- Vitrification, Egg Freezing, Oocyte Cryopreservation
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Main Line Fertility CenterUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Aug 2011
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 24 Aug 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.
Indications for oocyte (egg) vitrification (fast freezing) include the preservation of reproductive competence of young cancer patients who need chemotherapy, pelvic radiation, or surgical removal of ovaries for treatment. Furthermore, the ability to freeze oocytes allows patients to reduce the number of embryos frozen, thereby circumventing the moral and ethical dilemmas of having left-over embryos in cryostorage. In addition, oocyte cryopreservation could allow women to delay childbearing if they want or need to. Until recently, conventional cryopreservation protocols have remained too inefficient for practical application in an infertility center. Very little is known about the effects of vitrification on oocytes and subsequent embryo development, especially using the sibling model (group of oocytes from the same cohort of ovarian follicles within patient). The purpose of this study is to examine the effect of oocyte vitrification on fertilization rates, embryo quality and development.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| freezing | Experimental | Procedure: Freezing |
| No freezing | No intervention | – |
Who may qualify
- Ages
- 21 to 37 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- healthy women ages 21-37 (inclusive)undergoing IVF in an attempt to achieve pregnancy
- Day 2-4 FSH < 10 IU/ml, LH <12 IU/ml, and E2 <50 pg/ml
- Antimullerian Hormone (AMH) >1.5
- Between 5 and 20 basal antral follicles on day 2-4 of the menstrual cycle
- BMI >18 and <32
Key exclusion criteria (2 listed)
- Smokers
- Polycystic Ovarian Syndrome (PCO)
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 |
|---|---|---|
| FreezingVitrification | Procedure or surgery | freezing |
Primary outcome
fertilization rate
Time frame: 18 hours after insemination
Embryo Quality
Time frame: day 3 and day 5
Embryo Development
Time frame: Day 3 and day 5
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 4 Jun 2014.
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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.
Glassner J Michael, M.D. principal investigator
Main Line Fertility Center
Sharon H. Anderson, Ph.D study director
Main Line Fertility Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Freezing in people with Fertility, run by Main Line Fertility Center 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 5 inclusion and 2 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 4 Jun 2014. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
fertilization rate (time frame: 18 hours after insemination). The study lists 3 primary outcomes in all. 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 4 Jun 2014.