NCT05943353

Brief Summary

Absolute asthenozoospermia is a rare condition in men with an occurrence frequency of 1/5000 and greatly affects fertility product. Previous studies have shown that the ovum can be fertilized with live but immotile sperm. However, the selection of live sperm for ICSI in immotile sperm samples is challenging for embryologists. Prominently, Pentoxyfilline (PTX) is a methylxanthine derivative, is an inhibitor of phosphodiesterase activity and increases intracellular cAMP levels, which play an important role in sperm motility. In recent years, many studies have demonstrated the effectiveness of PTX for the group of spermatozoa, sperm carrying severe abnormalities. In Vietnam, the application of PTX in ICSI has not yet been done in assisted reproductive centers. It is necessary to evaluate the effectiveness of PTX on ICSI treatment results in order to replace traditional methods and optimize treatment outcomes for patients.

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
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2023

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

First Submitted

Initial submission to the registry

July 3, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 13, 2023

Completed
19 days until next milestone

Study Start

First participant enrolled

August 1, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2024

Completed
Last Updated

July 13, 2023

Status Verified

July 1, 2023

Enrollment Period

1 year

First QC Date

July 3, 2023

Last Update Submit

July 10, 2023

Conditions

in Vitro Fertilization

Keywords

PentoxifyllineSperm selectingAbsolute asthenozoospermiain Vitro Fertilization

Outcome Measures

Primary Outcomes (1)

  • Fertilization rate

    Total number of zygotes fertilized / total number of MII oocytes. zygote sperm is defined as a 2PN zygote at the time of testing fertilization17±1hours after ICSI

    16-18 hours after ICSI-PTX

Secondary Outcomes (5)

  • Rate of good embryos on day 3

    67-69 hours

  • Rate of good embryos on day 5

    114-118 hours

  • Clinical pregnancy rate

    Clinical pregnancy is defined as the presence of an intrauterine gestational sac on ultrasound from 5 weeks of age

  • Progressing pregnancy rate

    An advanced pregnancy was defined as having at least one gestational sac with a fetal heartbeat up to 12 weeks of age

  • Miscarriage rate

    Progressive miscarriage is defined as: before the end of the 22nd week of pregnancy in which the fetus is no longer viable and expelled from the uterus.

Study Arms (1)

non-randomized trials

OTHER
Other: Pentoxifylline

Interventions

PentoxifyllineOTHER

Prominently, Pentoxyfilline (PTX) is a methylxanthine derivative, is an inhibitor of phosphodiesterase activity and increases intracellular cAMP levels, which play an important role in sperm motility. The ability of PTX to improve sperm motility was first recognized in the study of Turner et al (1978). One of the advantages of PTX is that it significantly reduces the time to find and select motile sperm in cases of completely immotile sperm. In recent years, many studies have demonstrated the effectiveness of PTX for the group of spermatozoa, sperm carrying severe abnormalities. Therefore, the use of a sperm motility inducer such as PTX is a potential method to replace traditional ICSI sperm selection methods. Therefore, we performed this study with the aim to evaluate the effectiveness of PTX to select sperm in ICSI on the group of sperm that were completely immotile after ejaculation and obtained from the procedure.

non-randomized trials

Eligibility Criteria

Sexmale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Sperm are completely immotile since PESA, TESE and MicroTESE
  • Sperm are completely immotile after ejaculation

You may not qualify if:

  • Oocyte maturation cycle in vitro

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IVFMD, My Duc Hospital

Ho Chi Minh City, Vietnam

RECRUITING

MeSH Terms

Interventions

Pentoxifylline

Intervention Hierarchy (Ancestors)

TheobromineXanthinesPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Tuong M Ho, M.D

    Mỹ Đức Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tuong M Ho, M.D

CONTACT

+84903633377‬tuongho.ivfmd@gmail.com

Tuan M Vo, Bsc

CONTACT

+84969916537tuan.vm@myduchospital.vn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 3, 2023

First Posted

July 13, 2023

Study Start

August 1, 2023

Primary Completion

August 1, 2024

Study Completion

August 1, 2024

Last Updated

July 13, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

VN(1)