Lipidic Differences of Sperm Between Normal and Low Fertilization Patients

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.

Study Overview

• Status: Unknown
• Conditions: Fertilization
• Intervention / Treatment: Other: Lipid extraction

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 Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China, 710038
      • Recruiting
      • Tangdu Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Normal fertilization group; Sperm samples from the successful fertilization IVF cycles were collected.	Other: Lipid extraction; The sperm samples were used for lipid extraction. Lipids were analyzed using the UPLC-MS system.
Experimental: Low fertilization group; Sperm samples from the low fertilization IVF cycles were collected.	Other: Lipid extraction; The sperm samples were used for lipid extraction. Lipids were analyzed using the UPLC-MS system.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Normal fertilization rate	2PN (two pronuclei and two polar bodies) rate	6 months

Collaborators and Investigators

• Sponsor: Tang-Du Hospital
• Investigators: Study Chair: Li Bo, Doctor, Reproductive Medicine Center, Tangdu Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 3, 2020
• Primary Completion (Anticipated): October 31, 2020
• Study Completion (Anticipated): December 31, 2020

Study Registration Dates

• First Submitted: August 19, 2020
• First Submitted That Met QC Criteria: August 30, 2020
• First Posted (Actual): September 3, 2020

Study Record Updates

• Last Update Posted (Actual): September 3, 2020
• Last Update Submitted That Met QC Criteria: August 30, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: Lipid; Sperm; Fertilization; In vitro fertilization (IVF)
• Other Study ID Numbers: L0805

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No