FertilizationNCT04537481
Lipidic Differences of Sperm Between Normal and Low Fertilization Patients
A study testing Lipid extraction in people with Fertilization, run by Tang-Du Hospital at 1 site in China.
Trial summary
Although in vitro fertilization (IVF) involve the use of semen samples, there is little scientific methodology applied when selecting sperm. To select the most appropriate spermatozoa, first the operator need to define the optimal molecular markers. Read more about this study
- Who is it for?
- Ages 22 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fertilization
- What is being tested?
- Lipid extraction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 3 Aug 2020to 31 Dec 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 22 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Tubal factor infertility,
- The women's BMI (Body mass index) ranged from 18.5 to 24,
- The women's AMH (Anti-Müllerian hormone) ranged from 2 to 6.8 ng/ml,
- The oocyte mature rate was greater than 75%,
- 8 ≤ Number of retrieved oocytes ≤ 16.
- Analysis of the spouse's semen conventional parameters showed normal.
Who cannot join
- The age is over 35 years old.
- The women with polycystic ovary syndrome (PCOS).
- The endocrine function of the women was disordered.
- The women has metabolic disease.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tangdu Hospital
Xi'an, Shaanxi, 710038
wang ming, 8613259809290, wangmingbio@snnu.edu.cn
About this study
Official title: Lipidic Profiles Differences of Sperm Between Normal and Low Fertilization Male Patients in Vitro Fertilization
Although in vitro fertilization (IVF) involve the use of semen samples, there is little scientific methodology applied when selecting sperm. To select the most appropriate spermatozoa, first the operator need to define the optimal molecular markers. Sperm lipids may contribute to sperm function, thus the investigator's aim was to compare the lipidic profiles differences of sperm samples used in IVF cycles that ultimately led to normal fertilization or low fertilization.
Read the detailed description
There is increasing evidence that male fertility/infertility and sperm physiology are determined by multiple factors, necessitating the use of numerous molecular biomarkers to precisely assess male reproductive potential. The study has reported that the lipids are special interest as fertility markers and therapeutic targets not only due to their functions in sperm, but also because they are sensitive to external and environmental signals.
Sperm samples from infertile patients after IVF ( normal fertilization group, n=25; low fertilization group, n=25) were collected. Following standard density gradient separation operating procedure, the sample were incubated in 37°C, 5%CO2, for 3 hours. The sample included 10x10^6 spermatozoa after sample preparation and aliquots in 100 μL PBS were analyzed for lipid composition using ultra-high performance liquid chromatography coupled to mass spectrometry. Lipid compositions and levels were compared between the two groups. The results will describe the composition and contents of lipids linked to capacitation of sperm, opening a new possibilities for the development of male fertility diagnostic tools and culture media formulations to improve sperm quality and enhance fertilization result.
- Conditions
- Fertilization
- Being tested
- Lipid extraction
- Keywords
- In vitro fertilization (IVF), Sperm, Fertilization, Lipid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lipid extractionOther
The sperm samples were used for lipid extraction. Lipids were analyzed using the UPLC-MS system.
| Study group | Role | What they receive |
|---|---|---|
| Normal fertilization group | Experimental | Sperm samples from the successful fertilization IVF cycles were collected. Receives: Other: Lipid extraction |
| Low fertilization group | Experimental | Sperm samples from the low fertilization IVF cycles were collected. Receives: Other: Lipid extraction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Normal fertilization rate
2PN (two pronuclei and two polar bodies) rate
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2020
- Study start3 Aug 2020
- Primary completion31 Oct 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FertilizationStudies of the same condition, open and under way.
- More trials run by Tang-Du HospitalThe 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tang-Du Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Li Bo, Doctor, Study chair, Reproductive Medicine Center, Tangdu Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04537481
- Sponsor's protocol ID
- L0805
- Status last verified
- Aug 2020
- First submitted
- 19 Aug 2020
- Last updated
- 3 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lipidic Profiles Differences of Sperm Between Normal and Low Fertilization Male Patients in Vitro Fertilization
- ClinicalTrials.gov ID
- NCT04537481
- Acronym / sponsor ID
- L0805
- Conditions
- Fertilization
- Keywords
- In vitro fertilization (IVF), Sperm, Fertilization, Lipid
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Tang-Du HospitalUniversity, hospital or other
- Study start
- 3 Aug 2020 (actual)
- Primary completion
- 31 Oct 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 3 Sep 2020 (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.
Although in vitro fertilization (IVF) involve the use of semen samples, there is little scientific methodology applied when selecting sperm. To select the most appropriate spermatozoa, first the operator need to define the optimal molecular markers. Sperm lipids may contribute to sperm function, thus the investigator's aim was to compare the lipidic profiles differences of sperm samples used in IVF cycles that ultimately led to normal fertilization or low fertilization.
Detailed description
There is increasing evidence that male fertility/infertility and sperm physiology are determined by multiple factors, necessitating the use of numerous molecular biomarkers to precisely assess male reproductive potential. The study has reported that the lipids are special interest as fertility markers and therapeutic targets not only due to their functions in sperm, but also because they are sensitive to external and environmental signals.
Sperm samples from infertile patients after IVF ( normal fertilization group, n=25; low fertilization group, n=25) were collected. Following standard density gradient separation operating procedure, the sample were incubated in 37°C, 5%CO2, for 3 hours. The sample included 10x10^6 spermatozoa after sample preparation and aliquots in 100 μL PBS were analyzed for lipid composition using ultra-high performance liquid chromatography coupled to mass spectrometry. Lipid compositions and levels were compared between the two groups. The results will describe the composition and contents of lipids linked to capacitation of sperm, opening a new possibilities for the development of male fertility diagnostic tools and culture media formulations to improve sperm quality and enhance fertilization result.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal fertilization group | Experimental | Other: Lipid extractionSperm samples from the successful fertilization IVF cycles were collected. |
| Low fertilization group | Experimental | Other: Lipid extractionSperm samples from the low fertilization IVF cycles were collected. |
Who may qualify
- Ages
- 22 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Tubal factor infertility,
- The women's BMI (Body mass index) ranged from 18.5 to 24,
- The women's AMH (Anti-Müllerian hormone) ranged from 2 to 6.8 ng/ml,
- The oocyte mature rate was greater than 75%,
- 8 ≤ Number of retrieved oocytes ≤ 16.
Key exclusion criteria (4 listed)
- The age is over 35 years old.
- The women with polycystic ovary syndrome (PCOS).
- The endocrine function of the women was disordered.
- The women has metabolic disease.
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 |
|---|---|---|
| Lipid extractionThe sperm samples were used for lipid extraction. Lipids were analyzed using the UPLC-MS system. | Other | Low fertilization group, Normal fertilization group |
Primary outcome
Normal fertilization rate
Time frame: 6 months
2PN (two pronuclei and two polar bodies) rate
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2020.
- Individual participant dataSharing planned: No
Related trials for Fertilization
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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.
Li Bo, Doctor study chair
Reproductive Medicine Center, Tangdu Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lipid extraction in people with Fertilization, run by Tang-Du Hospital 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 6 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 3 Sep 2020. 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 Wang Ming, Master (8613259809290, wangmingbio@snnu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Normal fertilization rate (time frame: 6 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 3 Sep 2020; AzTrials last refreshed its copy on 3 Nov 2026.