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To compare the efficacy of platelet-rich plasma versus bone marrow-stem cell instillation in infertile women with decreased ovarian reserve undergoing IVF/ICSI treatment

An open labelled, three armed, randomised placebo controlled trial to study the effect of intra-ovarian platelet-rich plasma versus autologous adult bone marrow- derived stem cell instillation in poor ovarian responders - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/03/083537
Enrollment
39
Registered
2025-03-26
Start date
Unknown
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: N979- Female infertility, unspecified

Interventions

Intervention1: Intraovarian Platelet rich plasma: 2ml of Platelet rich plasma injected sub-cortically using a 35cm 17G single- lumen ovum pick-up needle with transvaginal ultrasound guidance under gen

Sponsors

AIIMS New Delhi
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Poor responder a. POSEIDON group 3 and 4 (Patient-Oriented Strategy Encompassing IndividualizeD Oocyte Number) The expected poor responder of any age group with poor ovarian reserve parameters (AFC less than 5 and/or AMH less than 1.2ng/ml) OR b. Poor ovarian responder: less than or equal to 3 oocytes retrieved in previous IVF cycles 2. Age: 21-45 years old 3. BMI: 18-35 kg/m2 4. Willing to give consent

Exclusion criteria

Exclusion criteria: 1.Patients with POI, Secondary ovarian failure (e. g., hypothalamic causes, chemotherapy, radiotherapy) 2. FSH more than 12 IU/ml 3. Chronic autoimmune diseases 4. Those with major medical problems such as malignancy, hepatitis 5. Known abnormal karyotyping 6. Ovarian Endometriosis (endometrioma) 7. Prior ovarian surgery 8. Active viral infections 9. Hematologic disorders, haemoglobin level of less than 11.0 g/dL or platelet count of less than 150,000/ul

Design outcomes

Primary

MeasureTime frame
1.Number of oocytes retrieved 2.Number of mature oocytes (MII) retrievedTimepoint: In one IVF cycle, 3 months after the intervention—

Secondary

MeasureTime frame
1. FSH, AMH levels 2. Antral Follicle Count, Ovarian volume 3. Dose of gonadotropins 4. Duration of gonadotropin stimulation 5. Level of E2 on the day of trigger 6. Fertilization rate 7. Cleavage rate 8. Blastulation rate 9. Number of good quality embryos 10. Cycle cancellation rate 11. Clinical pregnancy rate per embryo transfer 12. Cumulative clinical pregnancy rate 13. Safety outcomes (post-procedure) a. pain b. bleeding c. abscess or infection d. injury to any vital organs e. allergic reactions f. anaesthesia- related complications.Timepoint: In one IVF cycle, 3 months after the intervention—

Countries

India

Contacts

Public ContactDr Gunupuru Gayatri Swetha

All India Institute of Medical Sciences, New Delhi

malhotraneena@yahoo.com9891557707

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026