Establishing a Minimum Predictive Threshold Follicular Size and Oocyte Retrieval in ICSI Cycle

February 9, 2026 updated by: Ahmad Rashad Mahmoud Mostafa, Assiut University

Follicular Size and Oocyte Retrieval in ICSI Cycle : Establishing a Minimum Predictive Threshold. A Prospective Cohort Study

This study uses number and size of ovarian follicles on the day of ovulation trigger as key determinants for oocytes yield to optimize outcomes in IVF and ICSI Protocols

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

Accurate prediction of oocyte yield is a key factor in optimizing outcomes of in vitro fertilization (IVF) and intracytoplasmic sperm injection (ICSI) cycles. Follicle number and follicle diameter measured on the day of ovulation trigger are known to be strongly associated with oocyte retrieval and oocyte maturity. Larger follicles are more likely to yield mature (metaphase-II) oocytes, while smaller follicles contribute less consistently to oocyte yield.

Despite the established association between follicular size and oocyte maturity, there is currently no standardized clinical model that estimates the minimum expected number of retrieved oocytes based on the distribution of follicle diameters on the trigger day. Most existing studies focus on average outcomes rather than providing a practical tool to estimate the lowest anticipated oocyte yield for individual patients.

This study aims to estimate the minimum number of oocytes retrieved based on the number and diameter of ovarian follicles measured on the day of ovulation trigger. By developing a predictive approach based on follicular size distribution, this study seeks to support clinical decision-making, optimize trigger timing, and improve patient counseling regarding realistic expectations of oocyte yield.

Study Type

Observational

Enrollment (Estimated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Karima Sobhy M.Kholeif, Ph.D.
  • Phone Number: +01092698985
  • Email: Karema55@yahoo.com

Study Locations

  • Egypt
    • Asyut Governorate
      • Asyut, Asyut Governorate, Egypt, 71511
        • Assiut University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Female participants aged 18 to 35 years undergoing ICSI

Description

Inclusion Criteria:

  • women aged 18 to 35 years undergoing ICSI.
  • at least four follicles above 15 mm in diameter on the day of trigger
  • Downregulation using either GNRH antagonist or agonist protocol
  • Provision of written ,informed consent
  • BMI 18 to 35 kg per meter square

Exclusion Criteria:

  • anticipated poor responder, according to Bologna criteria
  • cycle canceled prior to retrieval or without trigger administration
  • Oocyte cryoperservation cycles or natural IVF cycles
  • presence of ovarian pathology affecting the follicular assessment (endometriosis,cysts )

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
ICSI observational Cohort
Participants will undergo standard ICSI procedures. Follicle size and number will be measured during ovarian stimulation; and oocyte yield will be see corded at retrieval. No additional interventions will be performed. The study aims to evaluate the predictive relationship between follicle characteristics and Oocyte yield

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total number of oocytes retrieved per participant during an ICSI cycle
Time Frame: From the start of controlled ovarian stimulation until the day of oocyte retrieval, assessed at oocyte retrieval (approximately 10-14 days after stimulation initiation and 34-36 hours after ovulation trigger).
The total number of oocytes retrieved will be recorded for each participant. Follicular number and mean follicular diameter will be measured by transvaginal ultrasound during ovarian stimulation, and their association with oocyte yield will be analyzed to determine minimum predictive thresholds for successful oocyte retrieval.
From the start of controlled ovarian stimulation until the day of oocyte retrieval, assessed at oocyte retrieval (approximately 10-14 days after stimulation initiation and 34-36 hours after ovulation trigger).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oocyte yield stratified by follicle size category and age group
Time Frame: From the start of controlled ovarian stimulation until the day of oocyte retrieval, assessed at oocyte retrieval (approximately 10-14 days after stimulation initiation and 34-36 hours after ovulation trigger).
The total number of oocytes retrieved per participant will be recorded and analyzed according to follicle size categories on the day of ovulation trigger. Participants will be stratified into predefined age groups (18-29 years and 30-35 years), and oocyte yield per follicle size category will be compared between age groups.
From the start of controlled ovarian stimulation until the day of oocyte retrieval, assessed at oocyte retrieval (approximately 10-14 days after stimulation initiation and 34-36 hours after ovulation trigger).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Study Chair: Alaa Ahmed Makhlouf, MD, Assiut University
  • Study Chair: Ahmed Abo-Elfadle, MD, Assiut University
  • Study Chair: Ahmed Mohamed Abo Elhasan Morsy, MD, Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 30, 2026

Primary Completion (Estimated)

December 30, 2029

Study Completion (Estimated)

December 30, 2030

Study Registration Dates

First Submitted

November 21, 2025

First Submitted That Met QC Criteria

December 28, 2025

First Posted (Actual)

January 12, 2026

Study Record Updates

Last Update Posted (Actual)

February 11, 2026

Last Update Submitted That Met QC Criteria

February 9, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Follicular size and ICSI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

No plan to share individual participant data is currently in place for this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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