InfertilityNCT01501292
Changes in the Distribution of Mitochondria During Oocyte Maturation
An observational study of Infertility, run by Hillel Yaffe Medical Center at 1 site in Israel.
Trial summary
Cytoplasmatic maturation is an important event in the general maturation of of the oocyte. Mitochondria is one of the major organelles involved in the process of cytoplasmatic maturation. Read more about this study
- Who is it for?
- Ages 18 to 44 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- Fixation and staining and Observation by laser microscopy
- How many people
- 20 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2012to Apr 2012
- 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 18 to 44 years
- Women only
- No healthy volunteers
- Adult
Study population: Patients undergoing routine in-vitro fertilization with ICSI
Who may be able to join
- Infertile patients needing IVF treatment
Who cannot join
- Patients not requiring the ICSI procedure
Trial locations and contacts
1 site in 1 country.
Israel1 site
Hillel Yaffe Medical Center
Hadera, 38100
Adrian Ellenbogen, MD
Ofer Fainaru, MD, PhD
About this study
Cytoplasmatic maturation is an important event in the general maturation of of the oocyte. Mitochondria is one of the major organelles involved in the process of cytoplasmatic maturation. The aim of this study is to investigate the presence and distribution of the mitochondria in the cytoplasma of immature oocytes that are retrieved in the routine in-vitro maturation cycle with intracytoplasmatic sperm injection (ICSI). These oocytes will not undergo ICSI because of their immaturity. Usually, they are discarded. In addition to these immature oocytes the investigators shall also investigate the mitochondria in mature oocytes that underwent ICSI but did not become fertilized and are discarded.
- Conditions
- Infertility
- Being tested
- Fixation and staining, Observation by laser microscopy
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fixation and stainingOther
Fixation and staining by MitiTracker Green FM
Observation by laser microscopyOther
Observation with Laser scanning confocal microscopy
| Study group | Role | What they receive |
|---|---|---|
| Immature oocytes (GV, M-I) | Not described Receives: Other: Fixation and staining; Other: Observation by laser microscopy | |
| Mature oocytes (M-II) | Not described Receives: Other: Fixation and staining; Other: Observation by laser microscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The patterns of mitochondrial distribution within the cytoplasma of oocytes during nuclear maturation
Identification the different patterns of mitochondrial distribution in correlation with the 3 stages nuclear maturation in human oocytes
Measured: Three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2011 (estimated)
- Study startJan 2012
- Primary completionApr 2012 (estimated)
- Study completionApr 2012 (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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hillel Yaffe Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01501292
- Sponsor's protocol ID
- 0095-11-HYMC
- Status last verified
- Dec 2011
- First submitted
- 13 Dec 2011
- Last updated
- 29 Dec 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in the Distribution of Mitochondria During Oocyte Maturation
- ClinicalTrials.gov ID
- NCT01501292
- Acronym / sponsor ID
- 0095-11-HYMC
- Conditions
- Infertility
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Hillel Yaffe Medical CenterOther government
- Study start
- Jan 2012
- Primary completion
- Apr 2012 (estimated)
- Study completion
- Apr 2012 (estimated)
- First posted
- 29 Dec 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.
Cytoplasmatic maturation is an important event in the general maturation of of the oocyte. Mitochondria is one of the major organelles involved in the process of cytoplasmatic maturation. The aim of this study is to investigate the presence and distribution of the mitochondria in the cytoplasma of immature oocytes that are retrieved in the routine in-vitro maturation cycle with intracytoplasmatic sperm injection (ICSI). These oocytes will not undergo ICSI because of their immaturity. Usually, they are discarded. In addition to these immature oocytes the investigators shall also investigate the mitochondria in mature oocytes that underwent ICSI but did not become fertilized and are discarded.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immature oocytes (GV, M-I) | – | Other: Fixation and staining, Other: Observation by laser microscopy |
| Mature oocytes (M-II) | – | Other: Fixation and staining, Other: Observation by laser microscopy |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients undergoing routine in-vitro fertilization with ICSI
Key inclusion criteria (1 listed)
- Infertile patients needing IVF treatment
Key exclusion criteria (1 listed)
- Patients not requiring the ICSI procedure
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 |
|---|---|---|
| Fixation and stainingFixation and staining by MitiTracker Green FM | Other | Immature oocytes (GV, M-I), Mature oocytes (M-II) |
| Observation by laser microscopyObservation with Laser scanning confocal microscopy | Other | Immature oocytes (GV, M-I), Mature oocytes (M-II) |
Primary outcome
The patterns of mitochondrial distribution within the cytoplasma of oocytes during nuclear maturation
Time frame: Three months
Identification the different patterns of mitochondrial distribution in correlation with the 3 stages nuclear maturation in human oocytes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2011.
Related trials for Infertility
RecruitingObservational study
International Pilot Study for Dual Non-invasive Assesment of Embryo Development
Infertility
Active, not recruitingObservational study
Retrieval of Sperm From Men With Azoospermia Using Ultrasound-guided Rete Testis Aspiration
Azoospermia, Nonobstructive, Infertility, Male
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)
RecruitingObservational study
Impact of Infertility on the Sexual Sphere in Couples Undergoing Assisted Reproduction
Sexual Health Quality of Life, Infertile Patients
RecruitingObservational study
Pilot Study of Discarded Blastocysts
Infertility (IVF Patients)
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.
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 Hillel Yaffe Medical Center at 1 site in Israel.
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 1 inclusion and 1 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 29 Dec 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 Israel. 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?
Contact Adrian Ellenbogen, MD (972-50-6246722, ellenbogen@hy.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The patterns of mitochondrial distribution within the cytoplasma of oocytes during nuclear maturation (time frame: Three months). 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 29 Dec 2011.