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

NCT ID: NCT02992756

Last Updated: 2025-05-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-29

Study Completion Date

2024-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Low Ovarian Reserve

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Growth Factors

Intervention Type DRUG

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

Interventions

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Growth Factors

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

Intervention Type DRUG

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

42 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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IVI Bilbao

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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IVI Bilbao

Leioa, Vizcaya, Spain

Site Status

Countries

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Spain

Other Identifiers

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1607-BIO-057-MF

Identifier Type: -

Identifier Source: org_study_id

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