NCT03734042

Brief Summary

All patients prepared to thawed embryo transfer were classified into 2 groups one group will receive platelet rich plasma (PRP) infusion intrauterine and the other group will not receive platelet rich plasma (PRP) infusion

Trial Health

87
On Track

Trial Health Score

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

Enrollment
102

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Dec 2018

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

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

November 6, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 7, 2018

Completed
24 days until next milestone

Study Start

First participant enrolled

December 1, 2018

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2021

Completed
Last Updated

November 29, 2021

Status Verified

November 1, 2021

Enrollment Period

2.9 years

First QC Date

November 6, 2018

Last Update Submit

November 26, 2021

Conditions

Evaluations

Keywords

Platelet rich plasmaIntrauterine infusionThawed embryosIVF/ICSI cycles

Outcome Measures

Primary Outcomes (2)

  • Endometrial thickness

    The increase in endometrial thickness at day of ET

    8 days

  • Pregnancy rate

    Number of cases who got pregnant

    15 days

Study Arms (2)

PRP group

EXPERIMENTAL

These patients will receive platelet rich plasma intrauterine infusion at day 11

Biological: Platelet rich plasma intrauterine infusion

Control group

PLACEBO COMPARATOR

These patients will receive intrauterine normal saline infusion at day 11

Biological: Normal saline

Interventions

Platelet rich plasma intrauterine infusionBIOLOGICAL

platelet rich plasma will be prepared, activated then infused by Intrauterine insemination catheter intrauterine at day 11

PRP group
Normal salineBIOLOGICAL

Intrauterine infusion of normal saline at day 11

Control group

Eligibility Criteria

Age20 Years - 35 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients age 20-35 years
  • Patients with previous implantation failure
  • Patients with thin endometrium\<7 mm

You may not qualify if:

  • Patients older than 40 years
  • Patients with fresh embryo transfer
  • Patients with abnormal uterine cavity septate, or bicornuate uterus
  • Patients with abnormal male factor or tubal factor
  • Patients with abnormal embryos grade B or C.
  • Patients with immunological disorders as thyroidits or systemic lupus or rheumatoid arthritis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ayman Shehata Dawood

Tanta, Egypt

Location

MeSH Terms

Interventions

Saline Solution

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 2 groups parallel
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

November 6, 2018

First Posted

November 7, 2018

Study Start

December 1, 2018

Primary Completion

October 31, 2021

Study Completion

October 31, 2021

Last Updated

November 29, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

not allowed

Locations

EG(1)