Influence of PRGF (Plasma Rich in Growth Factors) Puncture in Ovaries With Low Follicular Reservetechniques

Low Ovarian Reserve Clinical Trial

— PRGFO-2020  

Official title:

Influence of PRGF (Plasma Rich in Growth Factors) Puncture in Ovaries With Low Follicular Reserve

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02992756
• Other study ID #: 1607-BIO-057-MF
• Status: Recruiting
• Phase: Phase 3
• Start date: June 29, 2021
• Est. completion date: June 2023

Study information

• Verified date: February 2023
• Source: IVI Bilbao
• Contact: Marcos Ferrando, PhD
• Phone: 944806020
• Email: marcos.ferrando[@]ivirma.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Assisted reproduction patients candidates to an IVF/ICSI cycle with low follicular reserve:

after at least one cycle of stimulation obtaining 0-4 oocytes.

Improve the follicular response in patients with low response, increasing the number of follicles in subsequent cycles to treatment with growth factors.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 84
• Est. completion date: June 2023
• Est. primary completion date: June 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 42 Years

Eligibility

Inclusion Criteria:

1. Patients must give written consent.

2. To be a healthy woman acting voluntarily, aged 18 to 42 years (both inclusive) at the time of study selection time of selection for the study.

3. Have a BMI = 18 kg/m2 and = 35 kg/m2

4. Patients with low ovarian reserve (AMH <1.1 ng/mL) according to the Bologna criteria.

5. Patients who are going to undergo IVF/ICSI cycle with low follicular response: who after a previous cycle of stimulation have obtained 0-3 or more follicular 0-3 oocytes have been obtained after a previous stimulation cycle; or if 0-3 oocytes are expected to be obtained at the present time (less than 4 follicles).

oocytes (less than 4 follicles in the basal ultrasound).

6. To have recent analytical results (haemogram, biochemistry and coagulation); at least 11 months prior to inclusion in the study and a serology, according to clinical practice.

Translated with www.DeepL.com/Translator (free version)

Related Conditions & MeSH terms

• Low Ovarian Reserve

Intervention

Drug:
• Growth Factors
one dose 3-6 mL of PRP obtained by PRGF Endoret

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	Number of follicles recruited after instability of ovarian growth factors	o demonstrate an increase of at least 20% in the number of MII oocytes in a cycle after IVF/ICSI treatment with PRGF®-Endoret® compared to previous cycles in low IVF/ICSI patients.; IVF/ICSI treatment with PRGF®-Endoret® with respect to previous cycles in low responders.; responders	two months; Time included in two protocols of ovarian stimulation
Secondary	Rates of pregnancy rates	Increase pregnancy rates and decrease the number of cycles of accumulation of oocytes.	three months after embryo transfer after treatment of growth factors