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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 - Influence of instillation of PRGF in endometrial cavity

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2016-001716-38-ES
Enrollment
32
Registered
2016-11-17
Start date
2017-04-26
Completion date
Unknown
Last updated
2023-09-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Product Name: PRP (Obtenido por PRGF-Endoret) Pharmaceutical Form: Blood fraction modifier INN or Proposed INN: Platelet Rich Plasma Other descriptive name: AUTOLOGOUS PLASMA Concentration unit: ml m

Sponsors

IVI BILBAO
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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 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 32 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0

Exclusion criteria

Exclusion criteria: - History of pelvic inflammatory disease - Risk of infection

Design outcomes

Primary

MeasureTime frame
Main Objective: knowing the clinical value of using the PRGF-Endoret therapy and endometrial level applications to improve endometrial thickness endometrial preparations for embryo transfer.;Secondary Objective: 1. To evaluate the growth of endometrial thickness from the end of usual procedure stimulation until the end of use of the platelet plasma. 2. Analyze the impact of using platelet plasma on rates of implantation and pregnancy.;Primary end point(s): It is to find at least one difference 2mm increased endometrial wall;Timepoint(s) of evaluation of this end point: - Recruitment Period: June to October 2016 - Estimated to last patient treatment Date: January 2017 - End of the study Date: May 2017

Secondary

MeasureTime frame
Secondary end point(s): ASSESSMENT OF THE RATE OF IMPLEMENTATION Apply a bilateral Student t test comparison of the average rate of implementation in IVI over the past 4 years. ASSESSMENT OF PREGNANCY RATE Similarly, we apply a test of Fisher on a 2x2 design based on the results of gestation. It will be used as contrast group data IVI Bilbao in the last 4 years.;Timepoint(s) of evaluation of this end point: - Recruitment Period: June to October 2016 - Estimated to last patient treatment Date: January 2017 - End of the study Date: May 2017

Countries

Spain

Contacts

Public ContactFERNANDO QUINTANA

IVI BILBAO

fernando.quintana@ivi.es+34944806020

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026