Clinical trial

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

Name
1607-BIO-057-MF
Description
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.
Trial arms
Trial start
2021-06-29
Estimated PCD
2023-06-01
Trial end
2023-06-01
Status
Recruiting
Phase
Early phase I
Treatment
Growth Factors
one dose 3-6 mL of PRP obtained by PRGF Endoret
Arms:
Instillation of growth factors
Size
84
Primary endpoint
Number of follicles recruited after instability of ovarian growth factors
two months; Time included in two protocols of ovarian stimulation
Eligibility criteria
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)
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 84, 'type': 'ESTIMATED'}}
Updated at
2023-03-01

1 organization

1 product

1 indication

Organization
IVI Bilbao