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

Sponsor

Sara Rafael Fernandez (Other)

Overall Status

Recruiting

CT.gov ID

NCT03387501

Collaborator

(none)

Enrollment

Location

Arm

34.1

Anticipated Duration (Months)

0.4

Patients Per Site Per Month

Study Details

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)

Condition or Disease	Intervention/Treatment	Phase
Infertility Infertility, Female	Drug: Plasma rich in growth factors (PRGF-Endoret)	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

12 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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.

Actual Study Start Date :

May 27, 2019

Anticipated Primary Completion Date :

Dec 31, 2021

Anticipated Study Completion Date :

Mar 30, 2022

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: PRGF

Plasma rich in growth factors (PRGF) administration

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

Intrauterine administration of PRGF

Outcome Measures

Primary Outcome Measures

Percentage of women who achieve an endometrial thickness equal to or greater than 7 mm [3 days after administration of PRGF]
Measurement of the endometrial thickness by ultrasonography.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

Female

Accepts 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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital Clinico San Carlos	Madrid		Spain	28040

Sponsors and Collaborators

Sara Rafael Fernandez

Investigators

Study Chair: Sara Rafael, PhD, Hospital Clinico San Carlos

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Sara Rafael Fernandez, Head of Assisted Reproduction Laboratory, Hospital San Carlos, Madrid

ClinicalTrials.gov Identifier:

NCT03387501

Other Study ID Numbers:

APTE

First Posted:

Jan 2, 2018

Last Update Posted:

Jul 22, 2021

Last Verified:

Jul 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Infertility

Infertility, Female

Mitogens

Study Results

No Results Posted as of Jul 22, 2021