NCT04434495

Brief Summary

2 groups randomized to PRP injectioninto uterine cavity at mock embryo transfer, and a control group with only mock embryo transfer.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
788

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jun 2020

Shorter than P25 for phase_2

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

June 12, 2020

Completed
3 days until next milestone

Study Start

First participant enrolled

June 15, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 17, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2020

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2021

Completed
Last Updated

June 17, 2020

Status Verified

June 1, 2020

Enrollment Period

5 months

First QC Date

June 12, 2020

Last Update Submit

June 12, 2020

Conditions

Pregnancy Outcome

Keywords

PRP, IVF

Outcome Measures

Primary Outcomes (1)

  • Clinical pregnancy rate

    The presence of gestational sac by transvaginal ultrasound

    Four weeks post intervention

Secondary Outcomes (3)

  • Implantation rate

    Four weeks post intervention

  • Ongoing pregnancy rate

    Five months post intervention

  • Abortion rate

    Five months post intervention

Study Arms (2)

PRP group

EXPERIMENTAL

mock embryo transfer and PRP injection

Biological: PRP

control group

NO INTERVENTION

only mock embryo transfer

Interventions

PRPBIOLOGICAL

PRP injection into uterine cavity

PRP group

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Normoresponder patients (i.e. patients with 9 to 15 mature follicles on the day of HCG administration ) with expected good reproductive outcomes of IVF-ET and candidates for fresh embryo transfer

You may not qualify if:

  • Age less than 18 years and more than 35 years Body mass index more than 30kg/m2 Serum progesterone level less than 1.5 ng/ml on the trigger day Smoking Moreover, patients with previous IVF cycle, PCOS ( polycystic ovarian syndrome), pelvic inflammatory disease, endometriosis, uterine anomalies, Ashermann syndrome, chronic endometritis, chromosomal anomalies, increased peripheral NK cells, hereditary thrombophylia and antiphospholipid syndrome were excluded from the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Hisham Gouda, MD

    Assistant prof Cairo university

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hisham Gouda, MD

CONTACT

00201001885885Sheemer75@gmail.com

Omneya Osman, MD

CONTACT

00201006671777Omna03@gmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

June 12, 2020

First Posted

June 17, 2020

Study Start

June 15, 2020

Primary Completion

November 15, 2020

Study Completion

April 15, 2021

Last Updated

June 17, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share