Lipidic Differences of Sperm Between Normal and Low Fertilization Patients

Sponsor

Tang-Du Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT04537481

Collaborator

(none)

Enrollment

Location

Arms

4.9

Anticipated Duration (Months)

10.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Fertilization	Other: Lipid extraction	N/A

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

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

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

Actual Study Start Date :

Aug 3, 2020

Anticipated Primary Completion Date :

Oct 31, 2020

Anticipated Study Completion Date :

Dec 31, 2020

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Normal fertilization rate [6 months]
2PN (two pronuclei and two polar bodies) rate

Eligibility Criteria

Criteria

Ages Eligible for Study:

22 Years to 35 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tangdu Hospital	Xi'an	Shaanxi	China	710038

Sponsors and Collaborators

Tang-Du Hospital

Investigators

Study Chair: Li Bo, Doctor, Reproductive Medicine Center, Tangdu Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Tang-Du Hospital

ClinicalTrials.gov Identifier:

NCT04537481

Other Study ID Numbers:

L0805

First Posted:

Sep 3, 2020

Last Update Posted:

Sep 3, 2020

Last Verified:

Aug 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Tang-Du Hospital

In vitro fertilization (IVF)

Sperm

Fertilization

Lipid

Study Results

No Results Posted as of Sep 3, 2020