Repetition FailureNCT03639506
Clinical Application of Autologous Mitochondria Transplantation for Improving Oocyte Quality.
A study testing autologous mitochondria transplantation, autologous mitochondria from bone marrow mesenchymal stem cells into oocyte as well as intracytoplasmic sperm injection (ICSI) and intracytoplasmic sperm injection (ICSI) in people with Repetition Failure, run by Sun Yat-sen University.
Trial summary
Embryo quality was ranked as one of the most important predictors in determining the success of implantation, while clinically some patients may experience repeated IVF failure due to persistent poor embryo quality.Mitochondria, as the energy factory, is confirmed being a hallmark of quality and developmental… Read more about this study
- Who is it for?
- Ages 20 to 43 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Repetition Failure
- What is being tested?
- autologous mitochondria transplantation, autologous mitochondria from bone marrow mesenchymal stem cells into oocyte as well as intracytoplasmic sperm injection (ICSI) and intracytoplasmic sperm injection (ICSI)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Sep 2018to Sep 2021
- Phase
- Interventional
- 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 20 to 43 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women age >20 years and <43 years.
- Anti-müllerian hormone（AMH） level ≥1.1 ng/ml.
- Previous failed transfer cycle ≥2.
- BMI>18kg/m2 and <25kg/m2.
- Written informed consent.
Who cannot join
- Abnormal uterine development, endometrial adhesion or previous endometrial dysplasia (<7mm)
- Other medical diseases that cannot be pregnant.
- Complicated with adenomyosis, endometriosis confirmed by surgery, ovarian endometriosis cyst ≥2 cm by ultrasound, all kind of malignant tumors or precancerous disease.
- Untreated hydrosalpinx.
- The man has definite factors that affect the quality of the embryo, such as persistent abnormal DNA fragment rate (>30%) and non-obstructive spermatozoa.
- Intracytoplasmic sperm injection with donor.
- Eliminate or falls off Criteria:
- 1.The number of retrieved oocytes <6.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Pilot Study of the Effect of Autologous Mitochondria Transplantation in Assisted Reproductive Technology Clinical Outcome.
Embryo quality was ranked as one of the most important predictors in determining the success of implantation, while clinically some patients may experience repeated IVF failure due to persistent poor embryo quality.Mitochondria, as the energy factory, is confirmed being a hallmark of quality and developmental potential of human oocytes, and decreased mitochondria copy number was reported to be associated with oocyte aging and dysfunctional mitochondria would be expected to influence the late stages of oocyte maturation and early embryogenesis.The objective of this study is to evaluate the effect of mitochondria transfer from bone marrow mesenchymal stem cell on the quality of oocyte.
Read the detailed description
This study is a pilot study to investigate the effect of autologous mitochondria transplantation for improving oocyte quality.
Design: randomized controlled trial. Setting: Assisted reproductive technologies unit. Patients: patients who is in accordance with the inclusion criteria, and not meet the exclusion criteria, who had repeated IVF treatment from Sep 2018 to Sep 2021.
Intervention: The comparison was made between mitochondria transfer（MIT) group and the control group, both groups are conducted with the GnRH-a super-long protocol for IVF treatment. MIT group injects autologous mitochondria from bone mesenchymal stem cells into oocyte.
Main outcome measures: The primary outcome of the study is live birth rate. The secondary outcomes were clinical pregnancy rate, number of oocytes retrieved, fertility rate, normal fertilization rate, rate of transferable embryo and good quality embryo rate.
- Conditions
- Repetition Failure
- Being tested
- autologous mitochondria transplantation, autologous mitochondria from bone marrow mesenchymal stem cells into oocyte as well as intracytoplasmic sperm injection (ICSI), intracytoplasmic sperm injection (ICSI)
- Keywords
- repetition failure, autologous mitochondria transplantation, embryo quality, live birth rate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
autologous mitochondria transplantationProcedure or surgery
inject autologous mitochondria from bone marrow mesenchymal stem cells into oocyte
autologous mitochondria from bone marrow mesenchymal stem cells into oocyte as well as intracytoplasmic sperm injection (ICSI)Combination product
autologous mitochondria transplantation
intracytoplasmic sperm injection (ICSI)Drug
intracytoplasmic sperm injection (ICSI)
| Study group | Role | What they receive |
|---|---|---|
| autologous mitochondria transplantation | Experimental | inject autologous mitochondria from bone marrow mesenchymal stem cells into oocyte as well as intracytoplasmic sperm injection (ICSI) Receives: Procedure: autologous mitochondria transplantation; Combination Product: autologous mitochondria from bone marrow mesenchymal stem cells into oocyte as well as intracytoplasmic sperm injection (ICSI) |
| ICSI | Active comparator | only has intracytoplasmic sperm injection (ICSI) Receives: Drug: intracytoplasmic sperm injection (ICSI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
live birth rate
number of live birth/ transferred cycle.Compare the live birth rate between the two groups with SPSS 20.0.
Measured: 2-3years
Secondary outcomes (5)
clinical pregnancy rate
Clinical pregnancy means pregnancy sac is seen intrauterine under ultrasound 7 weeks after embryo transferred.
Clinical pregnancy rate(%): number of clinical pregnancy/transferred cycle.Compare the clinical pregnancy rate between the two group with SPSS 20.0.
Measured: 2-3years
number of oocytes retrieved
Compare the number of oocytes retrieved between the two group with SPSS 20.0.
Measured: 2-3years
fertility rate
Fertility rate(%): number of oocyte fertilized/ number of oocytes retrieved.Compare the fertility rate between the two group with SPSS 20.0.
Measured: 2-3years
normal fertility rate
Normal fertility rate(%): number of oocyte normally fertilized/ number of oocytes retrieved. Compare the normal fertility rate between the two group with SPSS 20.0.
Measured: 2-3years
good quality embryo rate
Cleavage embryo grades 1 or 2 with 6-10 blastomeres were considered good quality embryos. Good quality embryo rate(%): number of good quality embryo/number of fertilized oocytes.Compare the good quality embryo rate between the two group with SPSS 20.0.
Measured: 2-3years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2018
- Study startSep 2018 (estimated)
- Primary completionDec 2020 (estimated)
- Study completionSep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Repetition FailureStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanhong Deng, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03639506
- Sponsor's protocol ID
- newivf20180817
- Status last verified
- Aug 2018
- First submitted
- 17 Aug 2018
- Last updated
- 21 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Liu X, Wang D, Jia L, Chen W, Huang R, Fang C, Du C, Yang L, Liu X, Liang X. Autologous bone marrow mesenchymal stem cell mitochondrial transplantation in recurrent assisted reproductive technology failure: a randomized controlled trial. Stem Cell Res Ther. 2026 May 13;17(1):244. doi: 10.1186/s13287-026-05059-5.
PubMed 42129850
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of the Effect of Autologous Mitochondria Transplantation in Assisted Reproductive Technology Clinical Outcome.
- ClinicalTrials.gov ID
- NCT03639506
- Acronym / sponsor ID
- newivf20180817
- Conditions
- Repetition Failure
- Keywords
- repetition failure, autologous mitochondria transplantation, embryo quality, live birth rate
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- Sep 2018 (estimated)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Sep 2021 (estimated)
- First posted
- 21 Aug 2018 (actual)
- 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.
Embryo quality was ranked as one of the most important predictors in determining the success of implantation, while clinically some patients may experience repeated IVF failure due to persistent poor embryo quality.Mitochondria, as the energy factory, is confirmed being a hallmark of quality and developmental potential of human oocytes, and decreased mitochondria copy number was reported to be associated with oocyte aging and dysfunctional mitochondria would be expected to influence the late stages of oocyte maturation and early embryogenesis.The objective of this study is to evaluate the effect of mitochondria transfer from bone marrow mesenchymal stem cell on the quality of oocyte.
Detailed description
This study is a pilot study to investigate the effect of autologous mitochondria transplantation for improving oocyte quality.
Design: randomized controlled trial. Setting: Assisted reproductive technologies unit. Patients: patients who is in accordance with the inclusion criteria, and not meet the exclusion criteria, who had repeated IVF treatment from Sep 2018 to Sep 2021.
Intervention: The comparison was made between mitochondria transfer（MIT) group and the control group, both groups are conducted with the GnRH-a super-long protocol for IVF treatment. MIT group injects autologous mitochondria from bone mesenchymal stem cells into oocyte.
Main outcome measures: The primary outcome of the study is live birth rate. The secondary outcomes were clinical pregnancy rate, number of oocytes retrieved, fertility rate, normal fertilization rate, rate of transferable embryo and good quality embryo rate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| autologous mitochondria transplantation | Experimental | Procedure: autologous mitochondria transplantation, Combination Product: autologous mitochondria from bone marrow mesenchymal stem cells into oocyte as well as intracytoplasmic sperm injection (ICSI)inject autologous mitochondria from bone marrow mesenchymal stem cells into oocyte as well as intracytoplasmic sperm injection (ICSI) |
| ICSI | Active comparator | Drug: intracytoplasmic sperm injection (ICSI)only has intracytoplasmic sperm injection (ICSI) |
Who may qualify
- Ages
- 20 to 43 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Women age >20 years and <43 years.
- Anti-müllerian hormone（AMH） level ≥1.1 ng/ml.
- Previous failed transfer cycle ≥2.
- BMI>18kg/m2 and <25kg/m2.
- Written informed consent.
Key exclusion criteria (8 listed)
- Abnormal uterine development, endometrial adhesion or previous endometrial dysplasia (<7mm)
- Other medical diseases that cannot be pregnant.
- Complicated with adenomyosis, endometriosis confirmed by surgery, ovarian endometriosis cyst ≥2 cm by ultrasound, all kind of malignant tumors or precancerous disease.
- Untreated hydrosalpinx.
- The man has definite factors that affect the quality of the embryo, such as persistent abnormal DNA fragment rate (>30%) and non-obstructive spermatozoa.
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 |
|---|---|---|
| autologous mitochondria transplantationinject autologous mitochondria from bone marrow mesenchymal stem cells into oocyte | Procedure or surgery | autologous mitochondria transplantation |
| autologous mitochondria from bone marrow mesenchymal stem cells into oocyte as well as intracytoplasmic sperm injection (ICSI)autologous mitochondria transplantation | Combination product | autologous mitochondria transplantation |
| intracytoplasmic sperm injection (ICSI)intracytoplasmic sperm injection (ICSI) | Drug | ICSI |
Primary outcome
live birth rate
Time frame: 2-3years
number of live birth/ transferred cycle.Compare the live birth rate between the two groups with SPSS 20.0.
5 secondary outcomes
clinical pregnancy rate
Time frame: 2-3years
number of oocytes retrieved
Time frame: 2-3years
fertility rate
Time frame: 2-3years
normal fertility rate
Time frame: 2-3years
good quality embryo rate
Time frame: 2-3years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2018.
- Derived from this study: PubMed 42129850Liu X, Wang D, Jia L, Chen W, Huang R, Fang C, Du C, Yang L, Liu X, Liang X. Autologous bone marrow mesenchymal stem cell mitochondrial transplantation in recurrent assisted reproductive technology failure: a randomized controlled trial. Stem Cell Res Ther. 2026 May 13;17(1):244. doi: 10.1186/s13287-026-05059-5.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing autologous mitochondria transplantation, autologous mitochondria from bone marrow mesenchymal stem cells into oocyte as well as intracytoplasmic sperm injection (ICSI) and intracytoplasmic sperm injection (ICSI) in people with Repetition Failure, run by Sun Yat-sen University.
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 8 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 21 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
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 Xiaoyan Liang, MD. Prof. (020-38048013, lxyzy@263.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
live birth rate (time frame: 2-3years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03639506, which also lists 1 linked publication.
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 21 Aug 2018.