“Pilot, open, non-comparative study to evaluate the safety and efficacy of Factor-Rich Plasma Intraovarian Growth in Patients with Low Reserve Ovarian”

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Instituto De Investigacion Sanitaria Fundacion Jimenez Diaz

Participant type

Patients

Age range

18-64 years

Gender

Female

Therapeutic area

Phenomena and Processes [G] - Reproductive and Urinary Physiological Phenomena [G08]

Trial duration

29 May 2025 → ongoing

Decision date (initial)

2024-10-24

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

TheramexHealthcareSpain S.L. · BTI BiotechnologyIntitute S.L

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety

Evaluate the change in the number of oocytes retrieved between the in vitro fertilization (IVF) cycle prior to intraovarian PRGF administration and the cycle following the PRGF administration

Secondary objectives 5

1. Evaluate changes in the number of oocytes in metaphase II (MII).
2. Evaluate changes in other ovarian reserve markers (AMH, FSH, LH, estradiol and antral follicle count)
3. Analyze the results of the IVF-ICSI laboratory (fertilized oocytes, embryos obtained and Hight Quality Embryos).
4. Evaluate pregnancy and abortion rates.
5. Describe the complications related to the procedure.

Conditions and MedDRA coding

Low Reserve Ovarian

Study design 2 periods

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. Women of group 3 and 4 of the POSEIDON classification for low reserve: POSEIDON 3: patients ˂ 35 years of age with diminished ovarian reserve (AMH <1.2 ng/ml, AFC <5). POSEIDON 4: patients ≥ 35 years of age with diminished ovarian reserve (AMH <1.2 ng/ml, AFC <5).
2. Patients with at least one ovary.
3. Infertility for at least one year
4. Forecast of safe ovarian access on the day of puncture.
5. Patients who agree to participate and give their written consent

Exclusion criteria 11

1. Patients with diagnosis of clinical ovarian insufficiency
2. Pregnant patients
3. Current or previous IgA deficiency
4. Ovarian failure secondary to identify genetic causes
5. Presence of pelvic adhesions after abdominal surgery
6. Chronic use of aspirin, NSAIDs or anticoagulants
7. Patients with psychiatric disorder precluding participation in the study (including abuse or dependence on psychoactive substances
8. Obesity (BMI ≥ 30)
9. Current cigarettes smoking (≥ 15 cigarettes per day)
10. Patients affected by neoplastic disease
11. Infertility with severe male factor

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. Compare ovarian reserve markers before and after surgery. intervention: FSH (continuous quantitative variable); LH (continuous quantitative variable); Estradiol (continuous quantitative variable); AMH (continuous quantitative variable); RFA (discrete quantitative variable)
2. Compare results obtained in the IVF-ICSI laboratory before and after PRP infusion: Number of canceled pre-puncture cycles; Number of cycles canceled post-puncture; Number of oocytes recovered; Number of MII on the day of puncture; Number of fertilized oocytes; Number of embryos achieved per EOC cycles; Number of good quality embryos (quality A or B depending ASEBIR classification); Number of frozen embryos

Secondary endpoints 2

1. Compare pregnancy rates and collect pre-post treatment pregnancy-related complications:Number of pregnancies per cycle started; Number of pregnancies per transfer; Number of abortions; Frequency of twin pregnancy; Frequency of hemoperitoneum; Frequency of post-puncture infection
2. Endpoints necessary by testing the hypothesis: Causes of sterility; Time of sterility in years; Number of embryos transferred (1 or 2); Stage of transferred embryos; EOC days; Total dose of gonadotropins

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Instituto De Investigacion Sanitaria Fundacion Jimenez Diaz

Sponsor organisation

Instituto De Investigacion Sanitaria Fundacion Jimenez Diaz

Address

Calle De Isaac Peral 42 Oficinas 2a Planta Oficina 1

City

Madrid

Postcode

28015

Country

Spain

Scientific contact point

Organisation

Instituto De Investigacion Sanitaria Fundacion Jimenez Diaz

Contact name

Eva Cerezo

Public contact point

Organisation

Instituto De Investigacion Sanitaria Fundacion Jimenez Diaz

Contact name

Eva Cerezo

Locations

1 EU/EEA country · 2 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 6 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

3 submissions — initial application plus substantial / non-substantial modifications