NCT03387501

Brief Summary

This study evaluate the percentage of women with thin endometrium who achieve an endometrial thickness equal to or greater than 7 mm after administration of PRGF (plasma rich in growth factors)

Trial Health

87
On Track

Trial Health Score

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

Enrollment
13

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started May 2019

Typical duration for phase_2

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

December 22, 2017

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 2, 2018

Completed
1.4 years until next milestone

Study Start

First participant enrolled

May 27, 2019

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 26, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 26, 2022

Completed
Last Updated

September 8, 2022

Status Verified

September 1, 2022

Enrollment Period

3.2 years

First QC Date

December 22, 2017

Last Update Submit

September 7, 2022

Conditions

InfertilityInfertility, Female

Outcome Measures

Primary Outcomes (1)

  • Percentage of women who achieve an endometrial thickness equal to or greater than 7 mm

    Measurement of the endometrial thickness by ultrasonography.

    3 days after administration of PRGF

Study Arms (1)

PRGF

EXPERIMENTAL

Plasma rich in growth factors (PRGF) administration

Drug: Plasma rich in growth factors (PRGF-Endoret)

Interventions

Plasma rich in growth factors (PRGF-Endoret)DRUG

Intrauterine administration of PRGF

PRGF

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Women who signed informed consent.
  • Women who understand the Spanish language.
  • Women under 42 years

You may not qualify if:

  • Thrombopenia.
  • Congenital or acquired uterine malformations that reduce embryo implantation or term gestation.
  • Ovarian tumors.
  • Benign uterine tumors require surgical treatment
  • Local acute inflammatory diseases
  • Patients with malignant tumors requiring chemotherapy.
  • Patients with acute or chronic infectious or inflammatory diseases requiring active treatment with drugs that may interfere with implantation and gestation.
  • Chronic treatment with NSAIDs (Nonsteroidal anti-inflammatory drugs)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Clinico San Carlos

Madrid, 28040, Spain

Location

MeSH Terms

Conditions

InfertilityInfertility, Female

Interventions

Intercellular Signaling Peptides and Proteins

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy Complications

Intervention Hierarchy (Ancestors)

PeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Officials

  • Sara Rafael, PhD

    Hospital Clinico San Carlos

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Head of Assisted Reproduction Laboratory

Study Record Dates

First Submitted

December 22, 2017

First Posted

January 2, 2018

Study Start

May 27, 2019

Primary Completion

July 26, 2022

Study Completion

July 26, 2022

Last Updated

September 8, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)