Open, Non-comparative Pilot Study to Evaluate the Safety and Efficacy of Intraovarian Plasma Rich in Growth Factors (PRGF) in Patients With Low Ovarian Reserve

Официальное название

Open, Non-comparative, Pilot Study to Evaluate the Safety and Efficacy of Intraovarian Growth Factor-rich Plasma in Patients With Low Ovarian Reserve

Обзор

The use of plasma rich in growth factors (PRGF) improves ovarian reserve markers and IVF laboratory parameters in women with low ovarian reserve. Primary objective To compare ovarian reserve markers and IVF-ICSI laboratory results before and after PRGF infusion. Secondary Objectives * To compare pre- and post-treatment pregnancy rates. * To collect complications associated with the application of intraovarian PRGF. General Outline of the Study VISIT 1 * Patient Selection * Confirm that he/she has all the analyses and variables to be studied. * Signing of Informed Consent * Usual IVF protocol (1st IVF cycle) VISIT 2 * Instillation of intraovarian PRGF on the day of the puncture of the 1st IVF cycle in the FJD VISIT 3 * Analytical control at 4 weeks VISIT 4 * Analytical control at 8 weeks VISIT 5 * In case of failure to achieve gestation Start of 2nd cycle of IVF

Вмешательства

• Биопрепарат Plasma Rich in Growth Factors (PRGF)
  On the day of the ovarian puncture of the 1st IVF cycle, intraovarian instillation of plasma rich in growth factors will be performed.

Первичные конечные точки

• Number of cycles cancelled pre-puncture [Срок оценки: Day 1]
• Ovarian reserve markers [Срок оценки: Day 1 vs visit 4 weeks]
• Number of cycles cancelled post-puncture [Срок оценки: visit 4 weeks and visit 8 weeks]
• Number of oocytes recovered [Срок оценки: visit 4 weeks and visit 8 weeks]
• Number of MII (metaphase II stage oocyte) on the day of the puncture [Срок оценки: visit 2, day of the puncture (from the first day of menstruation, approximately 22 days later)]
• Number of fertilised oocytes [Срок оценки: visit 4 weeks and visit 8 weeks]
• Number of embryos obtained per EOC (ovarian stimulation) cycle [Срок оценки: visit 4 weeks and visit 8 weeks]
• Number of embryos of good quality (A or B quality according to ASEBIR classification). [Срок оценки: visit 4 weeks and visit 8 weeks]
• Number of frozen embryos [Срок оценки: visit 4 weeks and visit 8 weeks]

Критерии участия

Критерии включения

• Women of childbearing age as defined by the CTFG\*.
• Women in group 3 and 4 of the POSEIDON classification for low reserve:
• POSEIDON 3: patients ˂ 35 years of age with decreased ovarian reserve (AMH <1.2 ng/ml, AFC <5).
• POSEIDON 4: patients ≥ 35 years with decreased ovarian reserve (AMH <1.2 ng/ml, AFC <5).
• Patients with at least one ovary.
• Infertility of more than 1 year duration.
• Provision of safe ovarian access on the day of the puncture.
• They agree to participate and to give their written consent.

Критерии исключения

• Have a diagnosis of clinical ovarian insufficiency - Patients with an ongoing pregnancy - Patients with a clinical diagnosis of ovarian failure
• Patients with ongoing pregnancy
• Current or previous IgA deficiency,
• Ovarian failure secondary to identified genetic causes.
• Presence of pelvic adhesions after abdominal surgery.
• Chronic use of aspirin, NSAIDs or anticoagulants.
• Diseases that alter platelet number or function.
• Psychiatric disorder that precludes participation in the study (including active substance abuse or dependence).
• Obesity (BMI ≥ 30).
• Current female smokers (≥ 15 cigarettes per day) - Current smoking (≥ 15 cigarettes per day)
• Patients affected by neoplastic disease
• Severe male factor infertility

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Испания · 1 центр

• Hospital Universitario Fundación Jiménez Diaz — Madrid

Идентификаторы

NCT: NCT06975683 · URA-PRGF-01 · 2024-514444-87-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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