Influence of PRGF (Plasma Rich in Growth Factors) Puncture in Ovaries With Low Follicular Reservetechniques (PRGFO-2020)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Low Ovarian Reserve
• Intervention / Treatment: Drug: Growth Factors

• Study Type: Interventional
• Enrollment (Anticipated): 84
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Marcos Ferrando, PhD; Phone Number: 944806020; Email: marcos.ferrando@ivirma.com
• Study Contact Backup: Name: Fernando Quintana; Phone Number: 944806020; Email: fernando.quintana@ivirma.com

Study Locations

• Spain
  • Vizcaya
    • Leioa, Vizcaya, Spain, 48940
      • Recruiting
      • IVI Bilbao
      • Contact: Fernando Quintana; Phone Number: 944806020; Email: fernando.quintana@ivirma.com
      • Contact: Marcos Ferrando; Phone Number: 944806020; Email: marcos.ferrando@ivirma.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 42 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Instillation of growth factors; Patients candidates to an IVF/ICSI cycle with low follicular reserve: after at least one cycle of stimulation obtaining 0-3 oocytes.	Drug: Growth Factors; one dose 3-6 mL of PRP obtained by PRGF Endoret

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: IVI Bilbao

Study record dates

Study Major Dates

• Study Start (Actual): June 29, 2021
• Primary Completion (Anticipated): June 1, 2023
• Study Completion (Anticipated): June 1, 2023

Study Registration Dates

• First Submitted: December 2, 2016
• First Submitted That Met QC Criteria: December 12, 2016
• First Posted (Estimate): December 14, 2016

Study Record Updates

• Last Update Posted (Actual): March 1, 2023
• Last Update Submitted That Met QC Criteria: February 28, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Mitosis Modulators; Mitogens
• Other Study ID Numbers: 1607-BIO-057-MF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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