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

NCT ID: NCT07056400

Last Updated: 2026-01-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-03

Study Completion Date

2026-01-31

Brief Summary

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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.

Detailed Description

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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

Conditions

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Male Infertility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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first ejaculate

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.

Group Type EXPERIMENTAL

First Ejaculate for ICSI

Intervention Type PROCEDURE

Intervention 1: First Ejaculate for ICSI In this intervention, sperm collected from the first ejaculate will be used in Intracytoplasmic Sperm Injection (ICSI). The sperm will be analyzed for motility, morphology, and concentration before being used in fertilization and embryo culture. This arm will evaluate the quality of sperm obtained from the first ejaculate

Second Ejaculate

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

Group Type EXPERIMENTAL

Second Ejaculate for ICSI

Intervention Type PROCEDURE

In this intervention, sperm collected from the second ejaculate (obtained within 1-2 hours after the first ejaculate) will be used in Intracytoplasmic Sperm Injection (ICSI). The sperm will be analyzed for motility, morphology, and concentration before being used for fertilization and embryo culture. This arm will evaluate the quality of sperm obtained from the second ejaculate and its impact on fertilization rates and embryo development

Interventions

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First Ejaculate for ICSI

Intervention 1: First Ejaculate for ICSI In this intervention, sperm collected from the first ejaculate will be used in Intracytoplasmic Sperm Injection (ICSI). The sperm will be analyzed for motility, morphology, and concentration before being used in fertilization and embryo culture. This arm will evaluate the quality of sperm obtained from the first ejaculate

Intervention Type PROCEDURE

Second Ejaculate for ICSI

In this intervention, sperm collected from the second ejaculate (obtained within 1-2 hours after the first ejaculate) will be used in Intracytoplasmic Sperm Injection (ICSI). The sperm will be analyzed for motility, morphology, and concentration before being used for fertilization and embryo culture. This arm will evaluate the quality of sperm obtained from the second ejaculate and its impact on fertilization rates and embryo development

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

25 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Nour El-Hayat Fertility Center

Cairo, Cairo Governorate, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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Sci1312408001

Identifier Type: -

Identifier Source: org_study_id

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