---
title: Trial to Improve Fertilization Rate and Embryo Development in Intracytoplasmic Sperm Injection (ICSI) Cycles
nct_id: NCT07056400
overall_status: ACTIVE_NOT_RECRUITING
phase: NA
sponsor: Ain Shams University
study_type: INTERVENTIONAL
primary_condition: Male Infertility
countries: Egypt
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT07056400.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT07056400"
ct_last_update_post_date: 2026-01-05
last_seen_at: "2026-05-12T06:32:09.185Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Trial to Improve Fertilization Rate and Embryo Development in Intracytoplasmic Sperm Injection (ICSI) Cycles

**NCT ID:** [NCT07056400](https://clinicaltrials.gov/study/NCT07056400)

## Key Facts

- **Status:** ACTIVE_NOT_RECRUITING
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 108
- **Lead Sponsor:** Ain Shams University
- **Conditions:** Male Infertility
- **Start Date:** 2024-04-03
- **Completion Date:** 2026-01-31
- **CT.gov Last Update:** 2026-01-05

## 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.

## Detailed 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

## Eligibility

- **Minimum age:** 25 Years
- **Maximum age:** 45 Years
- **Sex:** MALE
- **Healthy Volunteers:** No

```
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.
```

## Arms

- **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.
- **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

## Interventions

- **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

- **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

- **Embryo development rate** _(time frame: periprocedural)_
- **semen analysis** _(time frame: Baseline)_

## Locations (1)

- Nour El-Hayat Fertility Center, Cairo, Cairo Governorate, Egypt

## Recent Field Changes (last 30 days)

- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.nour el-hayat fertility center|cairo|cairo governorate|egypt` — added _(2026-05-12)_

---

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*Source data (authoritative): https://clinicaltrials.gov/study/NCT07056400*  
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