Concentrate of Autologous Rich Plasma in Growth Factors in the Treatment of the Thin Endometrium (APTE)

September 7, 2022 updated by: Sara Rafael Fernandez

Efficacy and Safety of the Concentrate of Autologous Rich Plasma in Growth Factors in the Treatment of the Thin Endometrium in Patients Undergoing Transfer of Cryo-preserved Embryos: Clinical Trial II.

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)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain, 28040
        • Hospital Clínico San Carlos

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 36 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PRGF
Plasma rich in growth factors (PRGF) administration
Drug: Plasma rich in growth factors (PRGF-Endoret)
Intrauterine administration of PRGF

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of women who achieve an endometrial thickness equal to or greater than 7 mm
Time Frame: 3 days after administration of PRGF
Measurement of the endometrial thickness by ultrasonography.
3 days after administration of PRGF

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sara Rafael Fernandez

Investigators

  • Study Chair: Sara Rafael, PhD, Hospital Clínico San Carlos

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 27, 2019

Primary Completion (Actual)

July 26, 2022

Study Completion (Actual)

July 26, 2022

Study Registration Dates

First Submitted

December 22, 2017

First Submitted That Met QC Criteria

December 22, 2017

First Posted (Actual)

January 2, 2018

Study Record Updates

Last Update Posted (Actual)

September 8, 2022

Last Update Submitted That Met QC Criteria

September 7, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APTE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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