NCT07056400

Brief Summary

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.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
108

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

April 3, 2024

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

June 15, 2025

Completed
24 days until next milestone

First Posted

Study publicly available on registry

July 9, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2026

Completed
Last Updated

January 5, 2026

Status Verified

April 1, 2025

Enrollment Period

1.7 years

First QC Date

June 15, 2025

Last Update Submit

January 1, 2026

Conditions

Male Infertility

Outcome Measures

Primary Outcomes (1)

  • fertilization rate.

    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

    Periprocedural

Secondary Outcomes (2)

  • Embryo development rate

    periprocedural

  • semen analysis

    Baseline

Other Outcomes (2)

  • Clinical Pregnancy Rate

    up to 6 weeks

  • Sperm DNA Fragmentation index (DFI)

    Baseline

Study Arms (2)

first ejaculate

EXPERIMENTAL

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.

Procedure: First Ejaculate for ICSI

Second Ejaculate

EXPERIMENTAL

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

Procedure: Second Ejaculate for ICSI

Interventions

First Ejaculate for ICSIPROCEDURE

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

first ejaculate
Second Ejaculate for ICSIPROCEDURE

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

Second Ejaculate

Eligibility Criteria

Age25 Years - 45 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • Female with factors that might affect Oocyte quality:
  • Polycystic ovary (PCO). Poor ovarian reserve. Endometriosis.
  • \- Male partners who need testicular biopsy to retrieve sperms.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nour El-Hayat Fertility Center

Cairo, Cairo Governorate, 11762, Egypt

Location

MeSH Terms

Conditions

Infertility, Male

Interventions

Sperm Injections, Intracytoplasmic

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesInfertilityMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Fertilization in VitroReproductive Techniques, AssistedReproductive TechniquesTherapeuticsInvestigative Techniques

Study Design

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

Study Record Dates

First Submitted

June 15, 2025

First Posted

July 9, 2025

Study Start

April 3, 2024

Primary Completion

December 1, 2025

Study Completion

January 31, 2026

Last Updated

January 5, 2026

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)