NCT06663930

Brief Summary

New Approach For Ovarian PRP Injection for poor responders

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
21

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2024

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2024

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

October 19, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 29, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
Last Updated

October 29, 2024

Status Verified

October 1, 2024

Enrollment Period

1.3 years

First QC Date

October 19, 2024

Last Update Submit

October 26, 2024

Conditions

Poor Responders

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Age30 Years - 40 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
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

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Benha University

Banhā, benha, 13511, Egypt

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

October 19, 2024

First Posted

October 29, 2024

Study Start

March 1, 2024

Primary Completion

June 1, 2025

Study Completion

June 30, 2025

Last Updated

October 29, 2024

Record last verified: 2024-10

Locations

EG(1)