Lipidic Differences of Sperm Between Normal and Low Fertilization Patients

Fertilization Clinical Trial

Official title:

Lipidic Profiles Differences of Sperm Between Normal and Low Fertilization Male Patients in Vitro Fertilization

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04537481
• Other study ID #: L0805
• Status: Recruiting
• Phase: N/A
• Start date: August 3, 2020
• Est. completion date: December 31, 2020

Study information

• Verified date: August 2020
• Source: Tang-Du Hospital
• Contact: Wang Ming, Master
• Phone: 8613259809290
• Email: wangmingbio[@]snnu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 31, 2020
• Est. primary completion date: October 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 22 Years to 35 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Fertilization

Intervention

Other:
• Lipid extraction
The sperm samples were used for lipid extraction. Lipids were analyzed using the UPLC-MS system.

Locations

Country	Name	City	State
China	Tangdu Hospital	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Tang-Du Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Normal fertilization rate	2PN (two pronuclei and two polar bodies) rate	6 months