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

NCT02996760 | Terminated Phase 3 DMC

• 1 other identifier: 1404-BIO-019-MF
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Endometrial Development

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Analyze the impact of using platelet plasma on rates of implantation and pregnancy.

  During ovarian stimulation protocol 8-12 days

Study Arms (2)

Endometrium with less than 5mm

EXPERIMENTAL

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

Endometrium with more than 5mm

NO INTERVENTION

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

Interventions

Growth Factor, Platelet-Derived DRUG

0,5 mL, vaginal use , 3 dose number

Endometrium with less than 5mm

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• History of pelvic inflammatory disease
• Risk of infection

Sponsors & Collaborators

• IVI Bilbao: lead

Study Sites (1)

IVI Bilbao

Leioa, Vizcaya, 48940, Spain

Location

MeSH Terms

Interventions

Platelet-Derived Growth Factor

Intervention Hierarchy (Ancestors)

Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Blood Proteins; Proteins; Biological Factors

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2016
• First Posted: December 19, 2016
• Study Start: March 14, 2018
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: April 7, 2022

Record last verified: 2022-03

Locations

ES (1)