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NCT Number: NCT07056400

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Male Infertility Genital Diseases Genital Diseases, Male Infertility Infertility, Male Male Urogenital Diseases Urogenital Diseases

Age range

25 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Nour El-Hayat Fertility Center

Cairo, Cairo Governorate, 11762, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

First Ejaculate for ICSI

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 for ICSI

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

Primary outcomes

  1. fertilization rate.

    Time frame: Periprocedural

    Fertilization will be confirmed after 16-18 hours by the observation of two distinct pronuclei (2PN) and two polar bodies. The fertilization rate will be calculated as the number of fertilized oocytes divided by total number of mature oocytes (MII) for each couple. Oocytes with 2PN will be observed

Secondary outcomes

  1. Embryo development rate

    Time frame: periprocedural

    Oocytes with 2PN will be observed for embryonic development on day 2 and 3 until day 5 after micro-injection. The embryo development rates will be calculated as the number of embryos developed divided by the total number of mature oocytes for each couple.

  2. semen analysis

    Time frame: Baseline

    Semen samples will be analyzed in both the first and second ejaculate according to the World Health Organization (WHO) 2021 guidelines. The following parameters will be assessed:

    Semen volume (mL) Sperm concentration (million/mL) Total sperm count (million) Progressive motility (%) Total motility (%) Normal morphology (%) Analysis will be performed in a certified andrology laboratory using standardized techniques.

Other outcomes

  1. Clinical Pregnancy Rate

    Time frame: up to 6 weeks

    The clinical pregnancy rate will be assessed by detecting pregnancy via ultrasound after embryo transfer. This will help assess the long-term outcome of fertilization with sperm from the first and second ejaculates.

  2. Sperm DNA Fragmentation index (DFI)

    Time frame: Baseline

    Sperm DNA fragmentation will be assessed using the HALO test (sperm chromatin dispersion assay), following the manufacturer's protocol. The DNA fragmentation index (DFI) will be calculated as the percentage of sperm cells showing fragmented DNA.

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Jul 9, 2025
Registry last updated
Jan 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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