NCT04537481

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 3, 2020

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

August 19, 2020

Completed
15 days until next milestone

First Posted

Study publicly available on registry

September 3, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

September 3, 2020

Status Verified

August 1, 2020

Enrollment Period

3 months

First QC Date

August 19, 2020

Last Update Submit

August 30, 2020

Conditions

Fertilization

Keywords

In vitro fertilization (IVF)SpermFertilizationLipid

Outcome Measures

Primary Outcomes (1)

  • Normal fertilization rate

    2PN (two pronuclei and two polar bodies) rate

    6 months

Study Arms (2)

Normal fertilization group

EXPERIMENTAL

Sperm samples from the successful fertilization IVF cycles were collected.

Other: Lipid extraction

Low fertilization group

EXPERIMENTAL

Sperm samples from the low fertilization IVF cycles were collected.

Other: Lipid extraction

Interventions

Lipid extractionOTHER

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

Low fertilization groupNormal fertilization group

Eligibility Criteria

Age22 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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%,
  • ≤ Number of retrieved oocytes ≤ 16.
  • Analysis of the spouse's semen conventional parameters showed normal.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tangdu Hospital

Xi'an, Shaanxi, 710038, China

RECRUITING

Study Officials

  • Li Bo, Doctor

    Reproductive Medicine Center, Tangdu Hospital

    STUDY CHAIR

Central Study Contacts

Wang Ming, Master

CONTACT

8613259809290wangmingbio@snnu.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 19, 2020

First Posted

September 3, 2020

Study Start

August 3, 2020

Primary Completion

October 31, 2020

Study Completion

December 31, 2020

Last Updated

September 3, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)