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

NCT ID: NCT07331493

Last Updated: 2026-01-12

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-12-30
• Study Completion Date: 2030-12-30

Brief Summary

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

Detailed Description

Accurate prediction of oocyte yield is central to optimizing outcomes in in vitro fertilization (IVF) and intracytoplasmic sperm injection (ICSI) protocols. Among the key determinants, the number and size of ovarian follicles on the day of ovulation trigger have been consistently identified as critical predictors of both oocyte retrieval and maturation.

Several studies have demonstrated a strong association between follicle diameter and oocyte maturity. Follicles within the 16-22 mm range are significantly more likely to yield mature oocytes than smaller follicles (Haas et al., 2019; Mochtar et al., 2022). Analyses involving thousands of punctured follicles further confirmed that the likelihood of good-quality blastocyst formation increases progressively with follicle size up to approximately 19 mm, with diminishing returns thereafter (Weghofer et al., 2022).

More recently, large-scale data-driven approaches have refined these observations. A multicenter European cohort study of over 19,000 patients demonstrated that follicles measuring 13-18 mm contribute most substantially to the yield of metaphase-II (MII) oocytes, whereas the 14-20 mm range was most predictive of high-quality blastocyst development (Leijdekkers et al., 2024). Importantly, even after adjusting for age, ovarian reserve, and stimulation protocol, follicular size remained the dominant determinant of mature oocyte yield (Leijdekkers et al., 2024).

Despite these insights, there is still no standardized framework to estimate the minimum expected oocyte yield based on follicular size distribution. Given the pivotal role of oocyte number in clinical decision-making, counseling, and resource allocation, the development of a reliable predictive model represents an important unmet clinical need.

Despite this evidence, most studies have focused on average associations rather than defining a reliable minimum expected oocyte yield based on follicular size distribution. No standardized clinical model currently exists to translate follicle measurements into concrete expectations for the lowest anticipated number of retrieved oocytes. This lack of standardization limits clinicians' ability to optimize trigger timing, personalize stimulation protocols, and provide accurate counseling to patients regarding realistic outcomes. So, we are interested in this study to estimate the minimum number of oocytes retrieved based on the number and diameter of follicles measured on the day of ovulation trigger

Conditions

Follicular Size and Oocyte Retrieval in ICSI Cycle

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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

No interventions assigned to this group

Eligibility Criteria

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 )

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Ahmad Rashad Mahmoud Mostafa

Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alaa Ahmed Makhlouf, MD

Role: STUDY_CHAIR

Assiut University

Ahmed Abo-Elfadle, MD

Role: STUDY_CHAIR

Assiut University

Ahmed Mohamed Abo Elhasan Morsy, MD

Role: STUDY_CHAIR

Assiut University

Locations

Assiut University

Asyut, Asyut Governorate, Egypt

Countries

Egypt

Central Contacts

Ahmad Rashad Mahmoud Mostafa, MBBCh

Role: CONTACT

dr.arm99256@outlook.com

+201015655880

Karima Sobhy M.Kholeif, Ph.D.

Role: CONTACT

Karema55@yahoo.com

+01092698985

Related Links

http://www.eshre.eu/guidelines

This website provides the official ESHRE guidelines on a Varian stimulation, follicle monitoring and IVF and ICSI protocols, including definitions of poor ovarian response, which informed the design of this study

Other Identifiers

Follicular size and ICSI

Identifier Type: -

Identifier Source: org_study_id