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

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: Infertility; Infertility, Female
• Intervention / Treatment: Drug: Plasma rich in growth factors (PRGF-Endoret)

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 38 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

How is the study designed?

Design Details

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

Number of Arms

1

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	Measurement of the endometrial thickness by ultrasonography.	3 days after administration of PRGF

Collaborators and Investigators

• Sponsor: Sara Rafael Fernandez
• Investigators: Study Chair: Sara Rafael, PhD, Hospital Clinico San Carlos

Study record dates

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: Infertility; Infertility, Female; Molecular Mechanisms of Pharmacological Action; Mitosis Modulators; Mitogens
• 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