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Not yet recruiting NCT07331493

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

Observational Female Infertility

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Female Infertility. Basic parameters: 18 years — 35 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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 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.

Primary outcome measures

  • 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).]
Secondary outcome measures (1)
  • 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).]

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 )

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Egypt · 1 center
  • Assiut University — Asyut

Identifiers

NCT: NCT07331493 · Follicular size and ICSI

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗