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

Endometrial Development Clinical Trial

Official title:

Influence Instillation Plasma Rich in Growth Factors in Endometrial Cavity

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02996760
• Other study ID #: 1404-BIO-019-MF
• Status: Terminated
• Phase: Phase 3
• Start date: March 14, 2018
• Est. completion date: December 31, 2021

Study information

• Verified date: March 2022
• Source: IVI Bilbao
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 22
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 49 Years

Eligibility

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

Related Conditions & MeSH terms

• Endometrial Development

Intervention

Drug:
• Growth Factor, Platelet-Derived
0,5 mL, vaginal use , 3 dose number

Locations

Country	Name	City	State
Spain	IVI Bilbao	Leioa	Vizcaya

Sponsors (1)

Lead Sponsor	Collaborator
IVI Bilbao

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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