NCT04354363

Brief Summary

Infertility is a major problem nowadays

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

April 17, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 21, 2020

Completed
1 day until next milestone

Study Start

First participant enrolled

April 22, 2020

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2021

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2021

Completed
Last Updated

April 21, 2020

Status Verified

April 1, 2020

Enrollment Period

10 months

First QC Date

April 17, 2020

Last Update Submit

April 17, 2020

Conditions

Infertility

Outcome Measures

Primary Outcomes (1)

  • The number of women wo will have chemical pregnancy

    how many women will have chemical pregnancy

    within 3 months

Study Arms (2)

PRP

ACTIVE COMPARATOR

women who will receive PRP before ICSI

Other: Platelet rich plasma

No PRP

NO INTERVENTION

women who willnot receive PRP before ICSI

Interventions

Platelet rich plasmaOTHER

Giving women PRP before ICSI

PRP

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailswomen with infertility
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • women with primary infertility

You may not qualify if:

  • women with unexplained infertility

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Algazeerah

Giza, Egypt

Location

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Mahmoud Alalfy, PhD

    Algezeera hospitaland National Research Centre ,Egypt

    STUDY CHAIR

Central Study Contacts

Mahmoud Alalfy, PhD

CONTACT

01002611058mahmoudalalfy@ymail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: A randomized controlled trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 17, 2020

First Posted

April 21, 2020

Study Start

April 22, 2020

Primary Completion

February 15, 2021

Study Completion

March 1, 2021

Last Updated

April 21, 2020

Record last verified: 2020-04

Locations

EG(1)