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

Primary Purpose

Infertility, Infertility, Female

Status

Completed

Phase

Phase 2

Locations

Spain

Study Type

Interventional

Intervention

Plasma rich in growth factors (PRGF-Endoret)

About this trial

This is an interventional treatment trial for Infertility

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

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)

Sites / Locations

Hospital Clinico San Carlos

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PRGF

Arm Description

Plasma rich in growth factors (PRGF) administration

Outcomes

Primary Outcome Measures

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

Measurement of the endometrial thickness by ultrasonography.

Secondary Outcome Measures

Full Information

NCT ID

NCT03387501

First Posted

December 22, 2017

Last Updated

September 7, 2022

Sponsor

Sara Rafael Fernandez

1. Study Identification

Unique Protocol Identification Number

NCT03387501

Brief Title

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

Acronym

APTE

Official Title

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.

Study Type

Interventional

2. Study Status

Record Verification Date

September 2022

Overall Recruitment Status

Completed

Study Start Date

May 27, 2019 (Actual)

Primary Completion Date

July 26, 2022 (Actual)

Study Completion Date

July 26, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Sara Rafael Fernandez

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Infertility, Infertility, Female

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

13 (Actual)

8. Arms, Groups, and Interventions

Arm Title

PRGF

Arm Type

Experimental

Arm Description

Plasma rich in growth factors (PRGF) administration

Intervention Type

Drug

Intervention Name(s)

Plasma rich in growth factors (PRGF-Endoret)

Intervention Description

Intrauterine administration of PRGF

Primary Outcome Measure Information:

Title

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

Description

Measurement of the endometrial thickness by ultrasonography.

Time Frame

3 days after administration of PRGF

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sara Rafael, PhD

Organizational Affiliation

Hospital Clinico San Carlos

Official's Role

Study Chair

Facility Information:

Facility Name

Hospital Clinico San Carlos

City

Madrid

ZIP/Postal Code

28040

Country

Spain

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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