NCT03387501CompletedPhase 2
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.
Sara Rafael Fernandez1 site in 1 country13 target enrollmentStarted: May 27, 2019Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 13
- Locations
- 1
- Primary Endpoint
- Percentage of women who achieve an endometrial thickness equal to or greater than 7 mm
Study Overview
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)
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 40 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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)
Arms & Interventions
PRGF
Experimental
Plasma rich in growth factors (PRGF) administration
Intervention: Plasma rich in growth factors (PRGF-Endoret) (Drug)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Sara Rafael Fernandez
Head of Assisted Reproduction Laboratory
Hospital San Carlos, Madrid
Study Sites (1)
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