InfertilitySlow-freezeNCT00713869
Oocyte Cryopreservation: Evaluation of an Oocyte Freezing and Thawing Technique
An observational study of Infertility, run by West Coast Fertility Centers at 1 site in United States.
Trial summary
Over the past several decades, considerable effort has been expended toward the successful cryopreservation of various human cells. While attempts at cryopreservation have been directed at different tissue types, one of the most vigorously pursued targets has been reproductive tissue. Read more about this study
- Who is it for?
- Ages 21 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2006to Apr 2011
- 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 21 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Infertility patient
Who may be able to join
- To be eligible for inclusion into this study, each subject must satisfy the following criteria:
- Infertile woman wishing to conceive and whose physician has recommended that she undergo IVF.
- Participants must be aged 21 to 35 years
- Body mass index (BMI) < 38.
- Serum results for cycle day 3 FSH <10 mIU/ml.
- Must have male partner whose semen analysis meets the clinic criteria for ICSI. Use of donor sperm is also acceptable.
- Be willing and able to comply with the protocol for the duration of the study.
- Have voluntarily provided written informed consent under WIRB, prior to any study-related procedure that is not part of normal medical care, with the understanding that the subjects may withdraw consent before they start Lupron without prejudice to their future medical care.
Who cannot join
- A patient may NOT be entered into the study if she presents with ANY of the following criteria:
- Clinically significant systemic disease.
- Known endometriosis Grade III - IV (ASRM classification).
- Any previous cycle indicating a low response to gonadotropin stimulation (defined as retrieval of < 10 eggs at retrieval)
- Three or more previous ART cycles without a clinical pregnancy
- Abnormal, undiagnosed, gynecological bleeding.
Show all 13Show fewer
- Previous ovarian surgery
- Known allergy or hypersensitivity to recombinant gonadotropin preparations or any other study-related medications.
- Known current substance abuse.
- Simultaneous participation in another clinical trial.
- Current smoker.
- An extrauterine pregnancy within the last 3 months before OCP treatment commences.
- Previous participation in similar study at different centers.
Trial locations and contacts
1 site in 1 country.
United States1 site
West Coast Fertility Centers
Fountain Valley, California, 92708
About this study
Official title: Evaluation of the Affects of an Oocyte Freezing and Thawing Technique in Patients Undergoing In-vitro Fertilization (IVF)
Over the past several decades, considerable effort has been expended toward the successful cryopreservation of various human cells. While attempts at cryopreservation have been directed at different tissue types, one of the most vigorously pursued targets has been reproductive tissue. Historically, cryopreservation of human sperm has existed for several decades. The earliest reports of pregnancies (Trounson et al., 1983) and births (Zeilmaker et al., 1984) from the cryopreservation of human embryos occurred in the early 1980s. Presently, the freezing and storage of human embryos following in vitro fertilization (IVF) is standard practice at most fertility clinics. In 2003, the CDC Assisted Reproductive Technology success rates report stated that 4,246 live births occurred out of 17,517 non-donor frozen embryo cycles. . Because the human egg is a relatively voluminous cell with abundant cytoplasm, crystallization at the time of freezing may result in damage to the organelles. Secondly, a mature metaphase II oocyte contains a fragile spindle apparatus involved in cleavage.
The purpose of this research study is to evaluate a method of freezing and thawing oocytes. This evaluation will be made by comparing the survival rates and rates of fertilization, cleavage and embryo quality of fresh oocytes and frozen-thawed oocytes which will be inseminated during the IVF (in vitro fertilization) treatment cycle. In addition, the same comparisons will be made between frozen oocytes from infertile women and those of egg donors. You are being asked to be in this study because you are currently undergoing in vitro fertilization.
- Conditions
- Infertility
- Keywords
- Oocyte cryopreservation, Slow freeze
- Medical subject headings
- Infertility
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 |
|---|---|---|
| 1 | Patients between the ages of 21 and 35 undergoing in-vitro fertilization will be included in this study. | |
| 2 | Recipients using only frozen donor eggs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freeze / thaw survival rates. Fertilization rates. Cleavage rates. Embryo quality measured by pronuclear and day 2 morphology.
Measured: When oocyte thawed initiate.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2008 (estimated)
- Study startApr 2006
- Primary completionNov 2009 (estimated)
- Study completionApr 2011 (estimated)
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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West Coast Fertility Centers
- Sponsor type
- University, hospital or other
- Investigators
- David G. Diaz, MD, Principal investigator, West Coast Fertility Centers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00713869
- Sponsor's protocol ID
- 20052092
- Acronym
- Slow-freeze
- Status last verified
- Jan 2011
- First submitted
- 9 Jul 2008
- Last updated
- 6 Jan 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Affects of an Oocyte Freezing and Thawing Technique in Patients Undergoing In-vitro Fertilization (IVF)
- ClinicalTrials.gov ID
- NCT00713869
- Acronym / sponsor ID
- Slow-freeze / 20052092
- Conditions
- Infertility
- Keywords
- Oocyte cryopreservation, Slow freeze
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- West Coast Fertility CentersUniversity, hospital or other
- Study start
- Apr 2006
- Primary completion
- Nov 2009 (estimated)
- Study completion
- Apr 2011 (estimated)
- First posted
- 14 Jul 2008 (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.
Over the past several decades, considerable effort has been expended toward the successful cryopreservation of various human cells. While attempts at cryopreservation have been directed at different tissue types, one of the most vigorously pursued targets has been reproductive tissue. Historically, cryopreservation of human sperm has existed for several decades. The earliest reports of pregnancies (Trounson et al., 1983) and births (Zeilmaker et al., 1984) from the cryopreservation of human embryos occurred in the early 1980s. Presently, the freezing and storage of human embryos following in vitro fertilization (IVF) is standard practice at most fertility clinics. In 2003, the CDC Assisted Reproductive Technology success rates report stated that 4,246 live births occurred out of 17,517 non-donor frozen embryo cycles. . Because the human egg is a relatively voluminous cell with abundant cytoplasm, crystallization at the time of freezing may result in damage to the organelles. Secondly, a mature metaphase II oocyte contains a fragile spindle apparatus involved in cleavage.
The purpose of this research study is to evaluate a method of freezing and thawing oocytes. This evaluation will be made by comparing the survival rates and rates of fertilization, cleavage and embryo quality of fresh oocytes and frozen-thawed oocytes which will be inseminated during the IVF (in vitro fertilization) treatment cycle. In addition, the same comparisons will be made between frozen oocytes from infertile women and those of egg donors. You are being asked to be in this study because you are currently undergoing in vitro fertilization.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Patients between the ages of 21 and 35 undergoing in-vitro fertilization will be included in this study. |
| 2 | – | –Recipients using only frozen donor eggs |
Who may qualify
- Ages
- 21 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Infertility patient
Key inclusion criteria (8 listed)
- To be eligible for inclusion into this study, each subject must satisfy the following criteria:
- Infertile woman wishing to conceive and whose physician has recommended that she undergo IVF.
- Participants must be aged 21 to 35 years
- Body mass index (BMI) < 38.
- Serum results for cycle day 3 FSH <10 mIU/ml.
Key exclusion criteria (13 listed)
- A patient may NOT be entered into the study if she presents with ANY of the following criteria:
- Clinically significant systemic disease.
- Known endometriosis Grade III - IV (ASRM classification).
- Any previous cycle indicating a low response to gonadotropin stimulation (defined as retrieval of < 10 eggs at retrieval)
- Three or more previous ART cycles without a clinical 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
Freeze / thaw survival rates. Fertilization rates. Cleavage rates. Embryo quality measured by pronuclear and day 2 morphology.
Time frame: When oocyte thawed initiate.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2011.
- 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.
David G. Diaz, MD principal investigator
West Coast Fertility Centers
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 Infertility, run by West Coast Fertility Centers 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 8 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 6 Jan 2011. 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?
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?
Freeze / thaw survival rates. Fertilization rates. Cleavage rates. Embryo quality measured by pronuclear and day 2 morphology. (time frame: When oocyte thawed initiate.). 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 6 Jan 2011.