Trial to Improve Fertilization Rate and Embryo Development in Intracytoplasmic Sperm Injection (ICSI) Cycles

Ain Shams University

Status: Active, not recruiting

Conditions: Male Infertility

Treatments: Procedure: Second Ejaculate for ICSI; Procedure: First Ejaculate for ICSI

Study type: Interventional

Funder types: Other

Identifiers

NCT07056400

Sci1312408001

Details and patient eligibility

About

The Aim of the trial:

Assess if a consecutive second ejaculate contains an equal, or even higher number of motile sperm and produces high-quality sperm for intracytoplasmic sperm injection (ICSI) in male factor patients and if it will improve clinical outcomes, such as fertilization rate, embryo quality, number of blastocysts retrieved per cycle, implantation, and hopefully pregnancy rates.

Full description

Background:

According to research, the length of abstinence has an impact on sperm DNA fragmentation (SDF) as well as sperm parameters. Long abstinence period increases the volume of semen and the concentration of sperm, but it will negatively impact motility, viability, and morphology.

The second ejaculation of males shows a considerable improvement in total motility and a significant decrease in (SDF) when it is collected within 1 to 3 hours of the first ejaculate.

it is essential to ensure the availability of high-quality spermatozoa with second ejaculation to enhance clinical results in ICSI cycles

Enrollment: 108 estimated patients

Sex: Male

Ages: 25 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male: with abnormal semen parameter according to WHO.
• Age range between 25-45 for both partners.

Exclusion criteria

• Female with factors that might affect Oocyte quality:

Polycystic ovary (PCO). Poor ovarian reserve. Endometriosis.

- Male partners who need testicular biopsy to retrieve sperms.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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108 participants in 2 patient groups

first ejaculate

Experimental group

Description:

In this arm, participants will undergo ICSI using sperm collected from the first ejaculate. Semen analysis will be conducted to assess sperm quality, including motility, morphology, and concentration. This arm will serve as the baseline for comparison with the second ejaculate arm.

Treatment:

Procedure: First Ejaculate for ICSI

Second Ejaculate

Experimental group

Description:

Participants in this arm will undergo ICSI using sperm collected from the second ejaculate, which will be obtained within a short interval (1-2 hours) after the first. Semen analysis will be conducted to compare sperm quality with that of the first ejaculate, and fertilization and embryo development outcomes will be evaluated

Treatment:

Procedure: Second Ejaculate for ICSI