Infertility, MaleMASSNCT03968367
To Study the Effect of Magnetic Activated Sperm Sorting on the Outcome of in Vitro Fertilization-embryo Transplantation
A study testing Magnetic activated sperm sorting in people with Infertility, Male, run by Li-jun Ding at 1 site in China.
Trial summary
Recent studies have evaluated the use of magnetic-activated sperm sorting (MASS) to reduce apoptotic spermatozoa and improve the outcome of infertile male with assisted reproductive technology (ART). However, some results were inconsistent with above. Read more about this study
- Who is it for?
- Ages 20 to 45 years, men only
- Conditions the study is for
- Infertility, Male
- What is being tested?
- Magnetic activated sperm sorting
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 20 May 2019to 19 Jul 2020
- 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 45 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Patients were diagnostic as infertile according to 2007 WHO guidelines;
- DFI>25%.
Who cannot join
- With obvious female infertile factors;
- Sperm count <10 million;
- Chromosomal abnormalities in either or both of the couple;
- Loss of follow up or incomplete information of patients.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Reproductive Medicine Center, The affiliated Drum Towel Hospital of Nanjing University Medical School
Nanjing, Jiangsu, 210008
Haixiang Sun, +86 25 8310 7188, stevensunz@163.com
About this study
Official title: To Study the Effect of Magnetic Activated Sperm Sorting on the Outcome of in Vitro Fertilization-embryo Transplantation Among Patients With High DNA Fragmentation Index
Recent studies have evaluated the use of magnetic-activated sperm sorting (MASS) to reduce apoptotic spermatozoa and improve the outcome of infertile male with assisted reproductive technology (ART). However, some results were inconsistent with above. The sperm of male with abnormal semen analysis tend to be accompanied with high apoptotic and high DNA fragmentation index (DFI). Hence, this study aimed at determining the efficiency of MASS in improving the clinical outcome of patients with high DFI).
Read the detailed description
Patients will be recruited from our reproductive medicine center in Nanjing Drum towel Hospital, from July 2019 to July 2020. After semen analysis and selection of infertile men with at least two abnormal sperm parameters and obtaining the informed consent of the patients according to the admission criteria, the patients who enter the project will be randomly divided into the control group (n=30) whose sperm will be screened by density differential centrifugation (DGC) with swim up, and the observation group will be screened by MASS, followed by DGC. Then the procedure of in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) will be performed. Embryo transfer will be underwent according to the developmental speed and morphological characteristics of the embryo. The clinical outcomes after transplantation will be followed up.
- Conditions
- Infertility, Male
- Being tested
- Magnetic activated sperm sorting
- Keywords
- magnetic activated sperm sorting, DNA fragmentation index, sperm up, density differential centrifugation, clinical outcome
- Medical subject headings
- Infertility, Male
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic activated sperm sortingProcedure or surgery
Also called Magnetic activated cell sorting
MACS is a technique which allows the spermatozoa with the best characteristics to be selected for use in assisted reproduction treatments. This technique removes apoptotic spermatozoa - those which will die without achieving fertilisation - and selects the healthy ones, thus increasing the possibility of pregnancy.
| Study group | Role | What they receive |
|---|---|---|
| Magnetic activated sperm cell sorting for infertile man | Experimental | A 0.5 mL aliquot of spermatozoa suspended in HTF-modified HEPES buffer, obtained either after sperm wash to remove the seminal plasma or after DGC, was centrifuged and the pellet (maximum of 107 cells) was resuspended in 80 uL of binding buffer with 20 uL of Annexin V-conjugated microspheres, both from the Annexin V microbead kit (Miltenyi Biotec, Huburn, CA, USA), for 15 min at room temperature. After addition of 400 lL of binding solution, the suspension was placed in the separation column (MiniMACS, Miltenyi Biotec). Labeled (apoptotic) cells were retained on the column and non-labeled (viable) cells passed through the column. Receives: Procedure: Magnetic activated sperm sorting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pregnancy rate
Pregnancy rate was defined from posi tive blood HCG and ultrasonography findings showing at least one embryo with a foetal heart beat 5 weeks after transfer.
Measured: 2-3 months
Implantation rate
Implantation rate means the percentage of those embryos that implanted themselves into the uterine lining after having been transferred to the womb. Fetal heartbeat can be visualized via ultrasound in order to definitely confirm the implantation of the embryo.
Measured: 2-3 months
Live-birth rate
Live birth rate was defined as the number of deliveries that resulted in a live born neonate.
Measured: 1year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2019
- Study start20 May 2019
- Primary completion30 Apr 2020 (estimated)
- Study completion19 Jul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infertility, MaleStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Li-jun Ding
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Li-jun Ding, Nanjing University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03968367
- Sponsor's protocol ID
- SZ-2018-MASS1
- Acronym
- MASS
- Status last verified
- May 2019
- First submitted
- 28 May 2019
- Last updated
- 30 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Study the Effect of Magnetic Activated Sperm Sorting on the Outcome of in Vitro Fertilization-embryo Transplantation Among Patients With High DNA Fragmentation Index
- ClinicalTrials.gov ID
- NCT03968367
- Acronym / sponsor ID
- MASS / SZ-2018-MASS1
- Conditions
- Infertility, Male
- Keywords
- magnetic activated sperm sorting, DNA fragmentation index, sperm up, density differential centrifugation, clinical outcome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Li-jun DingUniversity, hospital or other
- Study start
- 20 May 2019 (actual)
- Primary completion
- 30 Apr 2020 (estimated)
- Study completion
- 19 Jul 2020 (estimated)
- First posted
- 30 May 2019 (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.
Recent studies have evaluated the use of magnetic-activated sperm sorting (MASS) to reduce apoptotic spermatozoa and improve the outcome of infertile male with assisted reproductive technology (ART). However, some results were inconsistent with above. The sperm of male with abnormal semen analysis tend to be accompanied with high apoptotic and high DNA fragmentation index (DFI). Hence, this study aimed at determining the efficiency of MASS in improving the clinical outcome of patients with high DFI).
Detailed description
Patients will be recruited from our reproductive medicine center in Nanjing Drum towel Hospital, from July 2019 to July 2020. After semen analysis and selection of infertile men with at least two abnormal sperm parameters and obtaining the informed consent of the patients according to the admission criteria, the patients who enter the project will be randomly divided into the control group (n=30) whose sperm will be screened by density differential centrifugation (DGC) with swim up, and the observation group will be screened by MASS, followed by DGC. Then the procedure of in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) will be performed. Embryo transfer will be underwent according to the developmental speed and morphological characteristics of the embryo. The clinical outcomes after transplantation will be followed up.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Magnetic activated sperm cell sorting for infertile man | Experimental | Procedure: Magnetic activated sperm sortingA 0.5 mL aliquot of spermatozoa suspended in HTF-modified HEPES buffer, obtained either after sperm wash to remove the seminal plasma or after DGC, was centrifuged and the pellet (maximum of 107 cells) was resuspended in 80 uL of binding buffer with 20 uL of Annexin V-conjugated microspheres, both from the Annexin V microbead kit (Miltenyi Biotec, Huburn, CA, USA), for 15 min at room temperature. After addition of 400 lL of binding solution, the suspension was placed in the separation column (MiniMACS, Miltenyi Biotec). Labeled (apoptotic) cells were retained on the column and non-labeled (viable) cells passed through the column. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patients were diagnostic as infertile according to 2007 WHO guidelines;
- DFI>25%.
Key exclusion criteria (4 listed)
- With obvious female infertile factors;
- Sperm count <10 million;
- Chromosomal abnormalities in either or both of the couple;
- Loss of follow up or incomplete information of patients.
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 |
|---|---|---|
| Magnetic activated sperm sortingAlso: Magnetic activated cell sortingMACS is a technique which allows the spermatozoa with the best characteristics to be selected for use in assisted reproduction treatments. This technique removes apoptotic spermatozoa - those which will die without achieving fertilisation - and selects the healthy ones, thus increasing the possibility of pregnancy. | Procedure or surgery | Magnetic activated sperm cell sorting for infertile man |
Primary outcome
Pregnancy rate
Time frame: 2-3 months
Pregnancy rate was defined from posi tive blood HCG and ultrasonography findings showing at least one embryo with a foetal heart beat 5 weeks after transfer.
Implantation rate
Time frame: 2-3 months
Implantation rate means the percentage of those embryos that implanted themselves into the uterine lining after having been transferred to the womb. Fetal heartbeat can be visualized via ultrasound in order to definitely confirm the implantation of the embryo.
Live-birth rate
Time frame: 1year
Live birth rate was defined as the number of deliveries that resulted in a live born neonate.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2019.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnetic activated sperm sorting in people with Infertility, Male, run by Li-jun Ding at 1 site in China.
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 2 inclusion and 4 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 30 May 2019. 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 China. 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 Haixiang Sun, phD (+86 2583107188, stevensunz@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pregnancy rate (time frame: 2-3 months). The study lists 3 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 30 May 2019.