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NCT Number: NCT07331493

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

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

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Key information

Age range

18 year–35 year

Sex eligibility

Female

Study type

Observational

Primary location

Assiut University

Asyut, Asyut Governorate, 71511, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 )

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  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).

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ahmad Rashad Mahmoud Mostafa, MBBCh

CONTACT

[email protected]

+201015655880

Karima Sobhy M.Kholeif, Ph.D.

CONTACT

[email protected]

+01092698985

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2029
Study completion
2030
First posted
Jan 12, 2026
Registry last updated
Feb 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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