Low Ovarian ReservePhase 1/2NCT01631578
Improving the Reproductive Outcome of Poor Quality Ova by Injection of Autologous Somatic Mitochondria
A Phase 1/2 study testing Injection of an autologous mitochondria to the oocyte. in people with Low Ovarian Reserve and Poor Quality Oocytes, run by Hadassah Medical Organization at 1 site in Israel.
Trial summary
A prospective randomized controlled trial (RCT) to determine the effect of injecting an autologous somatic mitochondria concentrate, together with the spermatozoon during ICSI, into oocytes of older and or poor prognosis in vitro fertilization (IVF) patients. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Low Ovarian Reserve, Poor Quality Oocytes
- What is being tested?
- Injection of an autologous mitochondria to the oocyte.
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2012to Aug 2015
- Phase
- Phase 1/2
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Adequate sperm source and uterine cavity. And one or more of the following:
- Age > 40
- 3 unsuccessful IVF cycles or
- > 75% of embryos in previous cycles with > 20-50% fragments or
- < 50% fertilization rate in previous cycles
Who cannot join
- Inadequate sperm source. Inadequate uterine cavity.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 1 Study of the Impact of Injecting an Autologous Somatic Mitochondrial Concentrate Into Poor Quality Ova.
A prospective randomized controlled trial (RCT) to determine the effect of injecting an autologous somatic mitochondria concentrate, together with the spermatozoon during ICSI, into oocytes of older and or poor prognosis in vitro fertilization (IVF) patients.
Read the detailed description
Maternal age at first delivery constantly rises in developed countries. Oocyte quality decreases with advanced age, thus the rate of age-related infertility continuously increases. Presently oocyte donation is the only prompt solution for this widespread problem. Deterioration of mitochondrial function was suggested as one of the explanations for the age-related deterioration of oocyte quality. The supplementation of the ageing oocyte with autologous mitochondria from dividing somatic cells can be a possible solution for energetic enrichment, without introducing foreign mtDNA.
We established a non-hazardous clinical grade system to prepare functional autologous mitochondria concentrate from the granulosa cells aspirated during oocyte pick up. The mitochondrial preparation was examined and found to be non-toxic. The activity of the respiratory chain was constant and unaffected by age or ovarian response. Moreover, the mtDNA in the mitochondrial preparation was found to be intact in all samples examined, including those from older and low responding patients.
- Conditions
- Low Ovarian Reserve, Poor Quality Oocytes
- Being tested
- Injection of an autologous mitochondria to the oocyte.
- Keywords
- mitochondrial injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Injection of an autologous mitochondria to the oocyte.Procedure or surgery
In the experimental group an autologous mitochondrial concentrate will be injected together with the sperm during ICSI. In the control group conventional ICSI will be performed.
| Study group | Role | What they receive |
|---|---|---|
| Injection of mitochondrial concentrate | Experimental | A small volume of mitochondrial concentrate will be injected together with the spermatozoon during ICSI. Receives: Procedure: Injection of an autologous mitochondria to the oocyte. |
| Control | Active comparator | ICSI will be performed conventionally. Receives: Procedure: Injection of an autologous mitochondria to the oocyte. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oocyte fertilization rate
Fertilization rate is assessed the day following oocyte retrieval.
Measured: one day
The rate pace and quality of the early embryonic development
The rate (the proportion of fertilized oocytes developing into embryos), pace of cleavage, and quality (morphological) of the early embryonic development will be assessed during the next 1-6 days (case specific).
Measured: up to 6 days
Secondary outcomes (1)
Clinical pregnancy
Measured: within 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2012 (estimated)
- Study startJan 2012
- Primary completionAug 2015
- Study completionAug 2015
Why it stopped: PI moved from medical center
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Ovarian ReserveStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe 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
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yoel Shufaro, MD PhD, Principal investigator, Hadassah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01631578
- Sponsor's protocol ID
- 252399- HMO-CTIL
- Status last verified
- Aug 2015
- First submitted
- 24 May 2012
- Last updated
- 20 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study of the Impact of Injecting an Autologous Somatic Mitochondrial Concentrate Into Poor Quality Ova.
- ClinicalTrials.gov ID
- NCT01631578
- Acronym / sponsor ID
- 252399- HMO-CTIL
- Conditions
- Low Ovarian Reserve, Poor Quality Oocytes
- Keywords
- mitochondrial injection
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI moved from medical center
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 29 Jun 2012 (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.
A prospective randomized controlled trial (RCT) to determine the effect of injecting an autologous somatic mitochondria concentrate, together with the spermatozoon during ICSI, into oocytes of older and or poor prognosis in vitro fertilization (IVF) patients.
Detailed description
Maternal age at first delivery constantly rises in developed countries. Oocyte quality decreases with advanced age, thus the rate of age-related infertility continuously increases. Presently oocyte donation is the only prompt solution for this widespread problem. Deterioration of mitochondrial function was suggested as one of the explanations for the age-related deterioration of oocyte quality. The supplementation of the ageing oocyte with autologous mitochondria from dividing somatic cells can be a possible solution for energetic enrichment, without introducing foreign mtDNA.
We established a non-hazardous clinical grade system to prepare functional autologous mitochondria concentrate from the granulosa cells aspirated during oocyte pick up. The mitochondrial preparation was examined and found to be non-toxic. The activity of the respiratory chain was constant and unaffected by age or ovarian response. Moreover, the mtDNA in the mitochondrial preparation was found to be intact in all samples examined, including those from older and low responding patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Injection of mitochondrial concentrate | Experimental | Procedure: Injection of an autologous mitochondria to the oocyte.A small volume of mitochondrial concentrate will be injected together with the spermatozoon during ICSI. |
| Control | Active comparator | Procedure: Injection of an autologous mitochondria to the oocyte.ICSI will be performed conventionally. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Adequate sperm source and uterine cavity. And one or more of the following:
- Age > 40
- 3 unsuccessful IVF cycles or
- > 75% of embryos in previous cycles with > 20-50% fragments or
- < 50% fertilization rate in previous cycles
Key exclusion criteria (1 listed)
- Inadequate sperm source. Inadequate uterine cavity.
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 |
|---|---|---|
| Injection of an autologous mitochondria to the oocyte.In the experimental group an autologous mitochondrial concentrate will be injected together with the sperm during ICSI. In the control group conventional ICSI will be performed. | Procedure or surgery | Control, Injection of mitochondrial concentrate |
Primary outcome
Oocyte fertilization rate
Time frame: one day
Fertilization rate is assessed the day following oocyte retrieval.
The rate pace and quality of the early embryonic development
Time frame: up to 6 days
The rate (the proportion of fertilized oocytes developing into embryos), pace of cleavage, and quality (morphological) of the early embryonic development will be assessed during the next 1-6 days (case specific).
1 secondary outcome
Clinical pregnancy
Time frame: within 2 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2015.
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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.
Yoel Shufaro, MD PhD principal investigator
Hadassah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Injection of an autologous mitochondria to the oocyte. in people with Low Ovarian Reserve and Poor Quality Oocytes, run by Hadassah Medical Organization 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 5 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: withdrawn, as of the sponsor's last update on 20 Aug 2015. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was withdrawn before enrolling participants, so there are no results.
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?
Oocyte fertilization rate (time frame: one day). The study lists 2 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 20 Aug 2015.