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

NCT02992756 | Terminated Phase 3 DMC

• 1 other identifier: 1607-BIO-057-MF
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Low Ovarian Reserve

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Rates of pregnancy rates

  three months after embryo transfer after treatment of growth factors

Study Arms (1)

Instillation of growth factors

EXPERIMENTAL

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

Interventions

Growth Factors DRUG

one dose 3-6 mL of PRP obtained by PRGF Endoret

Instillation of growth factors

Eligibility Criteria

• Age: 18 Years - 42 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients must give written consent.
• 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.
• Have a BMI ≥ 18 kg/m2 and ≤ 35 kg/m2
• Patients with low ovarian reserve (AMH \<1.1 ng/mL) according to the Bologna criteria.
• 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).
• Translated with www.DeepL.com/Translator (free version)

Sponsors & Collaborators

• IVI Bilbao: lead

Study Sites (1)

IVI Bilbao

Leioa, Vizcaya, 48940, Spain

Location

MeSH Terms

Interventions

Intercellular Signaling Peptides and Proteins

Intervention Hierarchy (Ancestors)

Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Design

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

Study Record Dates

• First Submitted: December 2, 2016
• First Posted: December 14, 2016
• Study Start: June 29, 2021
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: May 2, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)