Female InfertilityNCT07331493
Establishing a Minimum Predictive Threshold Follicular Size and Oocyte Retrieval in ICSI Cycle
An observational study of Female Infertility, run by Assiut University at 1 site in Egypt.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Female Infertility
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Apr 2026to 30 Dec 2030
- How long will I take part?
- 7 Weeks
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- No healthy volunteers
- Adult
Study population: Female participants aged 18 to 35 years undergoing ICSI
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Follicular Size and Oocyte Retrieval in ICSI Cycle : Establishing a Minimum Predictive Threshold. A Prospective Cohort Study
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
Read the 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.
- Conditions
- Female Infertility
- Keywords
- ICSI, Follicular size, Oocyte Retrieval, Oocyte yield, assisted reproduction
- Medical subject headings
- Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2026
- Study start30 Apr 2026 (estimated)
- Primary completion30 Dec 2029 (estimated)
- Study completion30 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Female InfertilityStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
- Target duration
- 7 Weeks
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmad Rashad Mahmoud Mostafa, Assiut University
- Investigators
- Alaa Ahmed Makhlouf, MD, Study chair, Assiut UniversityAhmed Abo-Elfadle, MD, Study chair, Assiut UniversityAhmed Mohamed Abo Elhasan Morsy, MD, Study chair, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07331493
- Sponsor's protocol ID
- Follicular size and ICSI
- Status last verified
- Feb 2026
- First submitted
- 21 Nov 2025
- Last updated
- 11 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: No plan to share individual participant data is currently in place for this study
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Follicular Size and Oocyte Retrieval in ICSI Cycle : Establishing a Minimum Predictive Threshold. A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT07331493
- Acronym / sponsor ID
- Follicular size and ICSI
- Conditions
- Female Infertility
- Keywords
- ICSI, Follicular size, Oocyte Retrieval, Oocyte yield, assisted reproduction
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 30 Apr 2026 (estimated)
- Primary completion
- 30 Dec 2029 (estimated)
- Study completion
- 30 Dec 2030 (estimated)
- First posted
- 12 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 7 Weeks
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Female participants aged 18 to 35 years undergoing ICSI
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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 )
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2026.
- 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 studyLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. No plan to share individual participant data is currently in place for this study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alaa Ahmed Makhlouf, MD study chair
Assiut University
Ahmed Abo-Elfadle, MD study chair
Assiut University
Ahmed Mohamed Abo Elhasan Morsy, MD study chair
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Female Infertility, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ahmad Rashad Mahmoud Mostafa, MBBCh (+201015655880, dr.arm99256@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2026.