InfertilityNCT00544531
The Cytogenetic Constitution of Embryos Resulting From Immature Oocytes (M1)
An observational study of Infertility, run by Assaf-Harofeh Medical Center at 1 site in Israel.
Trial summary
To examine the chromosomal number content in the blastomeres of embryos achieved from fertilization of immature oocytes at MI stage recruited following COH for IVF. comparison of the genetic number content of embryos and their quality in terms of cleavage rate and morphological score reached after fertilization of… Read more about this study
- Who is it for?
- Ages 25 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility
- How many people
- 23,907 participants
- Where
- 1 siteIsrael
- Study dates
- Oct 2005to Mar 2007
- 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 25 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients with presence of immature oocytes after ART stimulation
Who cannot join
- Patients with less than total 7 oocytes
Trial locations and contacts
1 site in 1 country.
About this study
To examine the chromosomal number content in the blastomeres of embryos achieved from fertilization of immature oocytes at MI stage recruited following COH for IVF.
comparison of the genetic number content of embryos and their quality in terms of cleavage rate and morphological score reached after fertilization of immature oocytes at MI stage whether arrested at the MI stage or extruded the polar body, after in vitro maturation for a variable length of time.
Read the detailed description
Patients undergoing routine IVF, following informed consent, donated some of their unusable, immature- MI stage oocytes for our research. Following in vitro maturation for up to 2, 4, 8 and 24 hours after harvest, all immature oocytes in these 4 study groups underwent intracytoplasmic donor sperm injection (ICSI), whether they extruded their polar body (MI-PB or rescued MI) or not (arrested MI). Oocyte fertilization rate after 24 hours and embryonic development in terms of cleavage rate and morphology were assessed, for another 48 hours. Then the whole embryo was prepared for molecular cytogenetic evaluation using FISH (Fluorescence in situ hybridization) analysis of chromosomes x, y and 18.
- Conditions
- Infertility
- Keywords
- MI oocytes, FISH,chromosomal aberrations
- Medical subject headings
- Infertility
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2007 (estimated)
- Study startOct 2005
- Study completionMar 2007
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
- Time perspective
- Prospective
- Enrolment
- 23,907 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assaf-Harofeh Medical Center
- Sponsor type
- Other government
- Investigators
- Raphael Ron-el, professor, Principal investigator, Assaf-Harofeh Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00544531
- Sponsor's protocol ID
- 76/05
- Status last verified
- Sep 2005
- First submitted
- 14 Oct 2007
- Last updated
- 16 Oct 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Cytogenetic Constitution of Embryos Resulting From Immature Oocytes (M1)
- ClinicalTrials.gov ID
- NCT00544531
- Acronym / sponsor ID
- 76/05
- Conditions
- Infertility
- Keywords
- MI oocytes, FISH,chromosomal aberrations
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 23,907 participants (actual)
- Lead sponsor
- Assaf-Harofeh Medical CenterOther government
- Study start
- Oct 2005
- Study completion
- Mar 2007 (actual)
- First posted
- 16 Oct 2007 (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.
To examine the chromosomal number content in the blastomeres of embryos achieved from fertilization of immature oocytes at MI stage recruited following COH for IVF.
comparison of the genetic number content of embryos and their quality in terms of cleavage rate and morphological score reached after fertilization of immature oocytes at MI stage whether arrested at the MI stage or extruded the polar body, after in vitro maturation for a variable length of time.
Detailed description
Patients undergoing routine IVF, following informed consent, donated some of their unusable, immature- MI stage oocytes for our research. Following in vitro maturation for up to 2, 4, 8 and 24 hours after harvest, all immature oocytes in these 4 study groups underwent intracytoplasmic donor sperm injection (ICSI), whether they extruded their polar body (MI-PB or rescued MI) or not (arrested MI). Oocyte fertilization rate after 24 hours and embryonic development in terms of cleavage rate and morphology were assessed, for another 48 hours. Then the whole embryo was prepared for molecular cytogenetic evaluation using FISH (Fluorescence in situ hybridization) analysis of chromosomes x, y and 18.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 25 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients with presence of immature oocytes after ART stimulation
Key exclusion criteria (1 listed)
- Patients with less than total 7 oocytes
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 16 Oct 2007.
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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.
Raphael Ron-el, professor principal investigator
Assaf-Harofeh Medical Center
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 Assaf-Harofeh 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: finished, as of the sponsor's last update on 16 Oct 2007. 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?
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 16 Oct 2007.