Influence Instillation Plasma Rich in Growth Factors in Endometrial Cavity Endometrial Development in Assisted Reproduction.

Influence Instillation Plasma Rich in Growth Factors in Endometrial Cavity

Women in assisted reproduction treatment they receive own or donated embryos and presenting an endometrial development less than 5 mm despite having received treatment with estrogen therapy knowing the clinical value of using the PRGF-Endoret therapy and endometrial level applications to improve endometrial thickness endometrial preparations for embryo transfer.

Study Overview

• Status: Terminated
• Conditions: Endometrial Development
• Intervention / Treatment: Drug: Growth Factor, Platelet-Derived

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Phase 3

Contacts and Locations

Study Locations

• Spain
  • Vizcaya
    • Leioa, Vizcaya, Spain, 48940
      • IVI Bilbao

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 49 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Women receiving cycle of oocytes outside or embryos (own / others), in the treatment of substituted cycle type.
• Less than 5mm despite 10 days with standard doses of estrogen therapy (6mg / 24h) Endometrio

Exclusion Criteria:

• History of pelvic inflammatory disease
• Risk of infection

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Endometrium with less than 5mm; Women receiving cycle of oocytes outside or embryos (own / others), in the treatment of substituted cycle type. Less than 5mm despite 10 days with standard doses of estrogen	Drug: Growth Factor, Platelet-Derived; 0,5 mL, vaginal use , 3 dose number
No Intervention: Endometrium with more than 5mm; Women receiving cycle of oocytes outside or embryos (own / others), in the treatment of substituted cycle type. More than 5mm despite 10 days with standard doses of estrogen

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate the growth of endometrial thickness	The endometrial thickness will be measured by vaginal ultrasound. Endometrium less than 5 mm will be treated	During ovarian stimulation protocol 8-12 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Analyze the impact of using platelet plasma on rates of implantation and pregnancy.	The biochemical determination of the hormone ßhcg will be performed 12 days after embryo transfer	During ovarian stimulation protocol 8-12 days

Collaborators and Investigators

• Sponsor: IVI Bilbao

Study record dates

Study Major Dates

• Study Start (Actual): March 14, 2018
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: December 2, 2016
• First Submitted That Met QC Criteria: December 14, 2016
• First Posted (Estimate): December 19, 2016

Study Record Updates

• Last Update Posted (Actual): April 7, 2022
• Last Update Submitted That Met QC Criteria: March 29, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Mitosis Modulators; Mitogens
• Other Study ID Numbers: 1404-BIO-019-MF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No