New Approach for Ovarian PRP Injection for Poor Responders | NCT06663930

Studies
New Approach for Ovarian PRP Injection for Poor Responders

NCT06663930

Sponsor

Bassem Ayman Mahmoud Assaf

Status

Active, not recruiting

Last Update Posted

Oct 29, 2024Actual

Enrollment

21Actual

Phase

Not provided

Conditions

Poor Responders

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

Oct 2024

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2024Actual

Primary Completion Date

Jun 1, 2025Estimated

Completion Date

Jun 30, 2025Estimated

First Submitted Date

Oct 19, 2024

First Submission Date that Met QC Criteria

Oct 26, 2024

First Posted Date

Oct 29, 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

Oct 26, 2024

Last Update Posted Date

Oct 29, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Not provided

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

New Approach For Ovarian PRP Injection for poor responders

Detailed Description

Poor ovarian responders are at high risk of unsuccessful IVF/ICSI trials. In the last few years, many studies showed significant improvement of ovarian reserve parameters after PRP injection. There was no consensus regarding the route of injection, the volume injected, the location of PRP injection inside the ovary, the number of injection and the number of the cycle in which PRP is injected.

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

21Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
PRP effect on ovary for better fertility outcome	This is a prospective cohort clinical observational study. Aiming at evaluating the clinical effects of injecting PRP(Platelet Rich Plasma) into ovaries, of poor responders, taking all measures which may improve the response rate. That is why we will inject PRP for 2 consecutive cycles, the first cycle via laparoscopy and the next cycle, via ultrasonography.	one year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

AMH : < 0.5 ng/ml
FSH: > 10 miu but < 25 miu.
AFC : < 5 in both ovaries
Poor ovarian response, in a previous IVF/ICSI trial , resulting in 3 or fewer oocytes.
Normal uterine cavity , demonstrated by a recent hysteroscopy

Exclusion Criteria:

Primary ovarian insufficiency with FSH > 25 miu.
Previous ovarian surgery or Chemotherapy.
On going Anticoagulant use.
Carcinomas or a history of chronic pelvic pain.
Present infection.
Hemoglobin level lower than 11 g/L
platelet count lower than 150 x 10³/μL.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

women attending their attempt of IVF/ICSI at Assaf Fertility center, after poor ovarian response in a previous trial, during the period March 2024 to June 2025

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Benha University		Banhā	benha	13511	Egypt