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

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ClinicalTrials.gov Identifier: NCT03387501
Recruitment Status : Not yet recruiting
First Posted : January 2, 2018
Last Update Posted : September 13, 2018
Sponsor:
Information provided by (Responsible Party):
Sara Rafael Fernandez, Hospital San Carlos, Madrid

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
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.
Estimated Study Start Date : October 2018
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : March 2021

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




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women who signed informed consent.
  • Women who understand the Spanish language.
  • Women under 40 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03387501


Contacts
Contact: Sara Rafael Fernandez +34 913303000 ext 3766 sara.rafael@salud.madrid.org

Sponsors and Collaborators
Sara Rafael Fernandez

Responsible Party: Sara Rafael Fernandez, Head of Assisted Reproduction Laboratory, Hospital San Carlos, Madrid
ClinicalTrials.gov Identifier: NCT03387501     History of Changes
Other Study ID Numbers: APTE
First Posted: January 2, 2018    Key Record Dates
Last Update Posted: September 13, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Infertility
Infertility, Female
Genital Diseases, Male
Genital Diseases, Female
Mitogens
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action