Infertility Urological and Genital Diseases
Conditions
Interventions
All included patients are treated with Exocomplex® Fertilità, a food supplement based on plant-derived extracellular vesicles (PDEVs) extracted from a mix of organically grown fruits and vegetables (t
Serono, Geneva, Switzerland) combined with pituitary suppression by a gonadotropin-releasing hormone (GnRH) antagonist (cetrorelix acetate, Cet
Sponsors
Exolab Italia S.r.l.
Eligibility
Sex/Gender
Female
Age
31 Years to 38 Years
Inclusion criteria
Inclusion criteria: 1. Women aged 31 to 38 years 2. Diagnosed with infertility (any cause) and scheduled for IVF-ET/ART treatment 3. Undergoing controlled ovarian stimulation (COS) protocol 4. BMI within normal to overweight range (as in study, matched groups) 5. No major systemic illnesses that could compromise ovarian function or ART outcomes 6. Provided written informed consent to participate in the study and share clinical outcomes
Exclusion criteria
Exclusion criteria: 1. Presence of severe systemic diseases (e.g., uncontrolled diabetes, cardiovascular disease, autoimmune disorders) that could compromise ART outcomes. 2. History of ovarian surgery or conditions leading to premature ovarian insufficiency. 3. Known chromosomal abnormalities or genetic disorders affecting fertility. 4. Use of experimental fertility treatments or participation in another interventional clinical trial within the past 3 months. 5. Active infections of the reproductive tract. 6. Current or recent (within 6 months) chemotherapy, radiotherapy, or other gonadotoxic treatments. 7. Known allergy or intolerance to components of the Exocomplex® supplement. 8. Substance abuse (alcohol, drugs, or other agents) that may interfere with ovarian function or ART outcomes. 9. Inability or unwillingness to comply with the study protocol or provide informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of retrieved oocytes, measured during the oocyte pick-up (OPU) procedure performed approximately 35 hours after ovulation triggering with leuprolide acetate (Lupron®), following controlled ovarian stimulation (COS) within a standard in vitro fertilization (IVF) protocol. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Number of secondary oocytes (metaphase I), measured by microscopic evaluation at the time of oocyte denudation following oocyte retrieval (OPU). 2. Number of inseminated oocytes, determined by counting the total oocytes subjected to fertilization by conventional IVF or intracytoplasmic sperm injection (ICSI) immediately after retrieval and denudation. 3. Number of fertilized oocytes, measured by microscopic evaluation of pronuclei formation (2PN stage) approximately 16–18 hours after insemination, under the same inverted microscope system. 4. Fertilization rate, calculated as the percentage of fertilized oocytes (2PN) over the total number of inseminated oocytes, measured 16–18 hours after insemination. 5. Embryo development rate, evaluated as the proportion of embryos reaching the blastocyst stage (day 5) under standard embryo culture conditions. Embryo morphology was assessed using an inverted Nikon Diaphot microscope (Eclipse TE 300; Nikon, Tokyo, Japan) equipped with a Hoffmann modulation contrast system at 400× magnification, according to standard morphological criteria to select the best embryos for transfer. 6. Clinical pregnancy rate, defined as the presence of a gestational sac visualized by transvaginal ultrasound 4–6 weeks after embryo transfer. | — |
Countries
Italy
Contacts
Public ContactMariantonia Logozzi
Outcome results
None listed