EFFICACY AND SAFETY OF THE CONCENTRATE OF AUTOMOTIVE RICH PLASMA IN GROWTH FACTORS IN THE TREATMENT OF THE FINE ENDOMETRY IN PATIENTS SUBMITTED TO TRANSFER OF CRIO-PRESERVED EMBRYOS: CLINICAL TRIAL III.

Phase 1

• Conditions: infertile women; MedDRA version: 20.0Level: PTClassification code 10056204Term: In vitro fertilisationSystem Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 20.0Level: LLTClassification code 10016463Term: Fertility decreased femaleSystem Organ Class: 100000024038; MedDRA version: 20.0Level: PTClassification code 10021928Term: Infertility femaleSystem Organ Class: 10038604 - Reproductive system and breast disorders; MedDRA version: 20.0Level: PTClassification code 10021926Term: InfertilitySystem Organ Class: 10038604 - Reproductive system and breast disorders; Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

• Registration Number: EUCTR2017-002267-18-ES
• Lead Sponsor: Sara Rafael Fernández

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-08-21
• Last Update Posted: 11 December 2017

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: 1

Inclusion Criteria

? Women who signed informed consent.
? Women who understand the Spanish language.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 12
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

? Thrombopenia.
? Coagulation problems.
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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Determine the percentage of women who achieve an endometrial thickness equal to or greater than 7 mm after administration of PRGF;Secondary Objective: Determine the endometrial thickness after intrauterine administration of autologous platelet concentrate.<br> Analyze the incidence of biochemical pregnancy <br>Analyze the percentage of women who achieve clinical gestation.<br> Evaluate the safety of PRGF administration. <br>Determine the number of newborn<br>Determine the number of abortions. <br>Determine the number of registered ectopic pregnancies. <br>Determine the number of women requiring administration of a second dose of PRGF. <br>To compare the number of pregnancies among women who received a dose of PRGF compared to those who received two doses;Primary end point(s): Percentage of women who achieve an endometrial thickness equal to or greater than 7 mm;Timepoint(s) of evaluation of this end point: 3 days after treatment

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): ? Thrombopenia.<br>? Coagulation problems.<br>Congenital or acquired uterine malformations that reduce embryo implantation or term gestation.<br>Ovarian tumors.<br>Benign uterine tumors require surgical treatment<br>? Local acute inflammatory diseases <br>? Patients with malignant tumors requiring chemotherapy.<br>? Patients with acute or chronic infectious or inflammatory diseases requiring active treatment with drugs that may interfere with implantation and gestation.;Timepoint(s) of evaluation of this end point: 3 days after the treatment<br>14 days after the treatment<br>Labour