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

NCT07331493 | Not Yet Recruiting DMC

• 1 other identifier: Follicular size and ICSI
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Female Infertility

Keywords

ICSI; Follicular size; Oocyte Retrieval; Oocyte yield; assisted reproduction

Outcome Measures

Primary Outcomes (1)

• Total number of oocytes retrieved per participant during an ICSI cycle

  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 Outcomes (1)

• Oocyte yield stratified by follicle size category and age group

  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).

Study Arms (1)

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

Eligibility Criteria

• Age: 18 Years - 35 Years
• Gender Eligibility Details: Only female participants are eligible because the study focuses on Oocyte retrieval during ICSI, which is a procedure performed in women
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Female participants aged 18 to 35 years undergoing ICSI

You may qualify if:

• 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

You may not qualify if:

• 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 )

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut University

Asyut, Asyut Governorate, 71511, Egypt

Location

Related Links

• 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

MeSH Terms

Conditions

Infertility, Female

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Infertility

Study Officials

• Alaa Ahmed Makhlouf, MD

  Assiut University

  STUDY CHAIR

• Ahmed Abo-Elfadle, MD

  Assiut University

  STUDY CHAIR

• Ahmed Mohamed Abo Elhasan Morsy, MD

  Assiut University

  STUDY CHAIR

Central Study Contacts

Ahmad Rashad Mahmoud Mostafa, MBBCh

CONTACT

+201015655880; dr.arm99256@outlook.com

Karima Sobhy M.Kholeif, Ph.D.

CONTACT

+01092698985; Karema55@yahoo.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 7 Weeks
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: November 21, 2025
• First Posted: January 12, 2026
• Study Start: April 30, 2026
• Primary Completion (Estimated): December 30, 2029
• Study Completion (Estimated): December 30, 2030
• Last Updated: February 11, 2026

Record last verified: 2026-02

Locations

EG (1)