Evaluation of Some Trace Elements in Follicular Fluid in... | NCT06719817

Studies
Evaluation of Some Trace Elements in Follicular Fluid in ICSI Cases and Their Effect on ICSI Outcomes

NCT06719817

Sponsor

Assiut University

Status

Recruiting

Last Update Posted

Dec 6, 2024Actual

Enrollment

154Estimated

Phase

Not provided

Conditions

Good Responders According to Guidelines Who Wre Charectarized by AMH>0.8ng/dl
Trace Elements in ICSI Cases

Interventions

Not provided

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 24, 2024Actual

Primary Completion Date

Aug 20, 2026Estimated

Completion Date

Sep 20, 2026Estimated

First Submitted Date

Oct 18, 2024

First Submission Date that Met QC Criteria

Dec 5, 2024

First Posted Date

Dec 6, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 5, 2024

Last Update Posted Date

Dec 6, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

To evaluate concentrations of some trace elements in the follicular fluid and their reproductive outcomes.

Detailed Description

To evaluate some trace elements in the follicular fluid and their reproductive outcome

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

154Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
oocyte maturity	Millimetres	2024 to 2026

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:good responders according to NICE guidelines with AMH more than 0.8ng/dl and antral follicular count more than 4 Exclusion Criteria:Poor responders according to ESHRE guidelines as advanced maternal age poor ovarian response and according to NICE guidelines AMH less than 0.8ng/dl

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Not provided

Minimum Age

25 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

good responders according to NICE guidelines with AMH more than 0.8ng/dl and antral follicular count more than 4

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Fatma Ahmed Waley	Contact	01064402617		www.fatma.waley@gmail.com
Ahmed Mohammed Nasr	Contact	01012588888		anasr@edu.eg

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Faculty of medicine	Recruiting	Asyut	Egypt		Egypt