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NCT03387501 Clinical Trial

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

Infertility Clinical Trial

— 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.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03387501
Other study ID # APTE
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date May 27, 2019
Est. completion date July 26, 2022

Study information
Verified date September 2022
Source Hospital San Carlos, Madrid
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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)

Recruitment information / eligibility
Status Completed
Enrollment 13
Est. completion date July 26, 2022
Est. primary completion date July 26, 2022
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 40 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• Plasma rich in growth factors (PRGF-Endoret)
Intrauterine administration of PRGF

Locations
Country Name City State
Spain Hospital Clinico San Carlos Madrid

Sponsors (1)
Lead Sponsor Collaborator
Sara Rafael Fernandez

Country where clinical trial is conducted

Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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