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

A

Assiut University

Status

Not yet enrolling

Conditions

Follicular Size and Oocyte Retrieval in ICSI Cycle

Study type

Observational

Funder types

Other

Identifiers

NCT07331493
Follicular size and ICSI

Details and patient eligibility

About

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

Full 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

Enrollment

60 estimated patients

Sex

Female

Ages

18 to 35 years old

Volunteers

No Healthy Volunteers

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 )

Trial design

60 participants in 1 patient group

ICSI observational Cohort
Description:
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

Trial contacts and locations

1

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Central trial contact

Ahmad Rashad Mahmoud Mostafa, MBBCh; Karima Sobhy M.Kholeif, Ph.D.

Data sourced from clinicaltrials.gov

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