Evaluation of the safety of intraovarian injection of exosomes derived from placental mesenchymal stem cells in infertile patients with diminished ovarian reserve

Intra-ovarian injection of exosomes derived from placental mesenchymal stem cells in infertile patients due to diminished ovarian reserves, production and evaluation of a biological product for infertility, a clinical trial phase 1

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

IRCT

Registry ID

IRCT20150722023298N4

Enrollment

Registered

2026-02-08

Start date

2025-12-22

Completion date

Unknown

Last updated

2026-06-01

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

Conditions

Infertile patients with diminished ovarian reserve. ?????? ????? ???? ?? ?????? ?? ??????? ???????

Interventions

Intervention 1: Intervention group: Group 1: Intraovarian injection of exosome dose 1 (50 Microgram/ml). In this group, 4 cc of exosome solution obtained from the supernatant of cultured placental mes

Eligibility

Sex/Gender

Female

Age

25 Years to 45 Years

Inclusion criteria

Inclusion criteria: Written informed consent Age between 25 and 45 years Not using OCP or Steroid supplements Normal fasting blood sugar level Normal serum sodium, potassium, calcium, phosphorus level Negative history of endometriosis or other ovarian cysts Negative history of previous ovarian surgery Negative history of cancer Normal liver tests (SGOT), (SGPT) Normal levels of thyroid hormones (TSH) and (FT4) Positive history of at least 1 previous standard IVF (in vitro fertilisation) - Embryo Transfer (ET) ?? ICSI (Intracytoplasmic Sperm Injection) Normal BUN, creatinine level Negative infection tests HIV, HCV, HBS Ag, VDRL Normal coagulation factors PT, PTT Level less than 1.1 ng/ml of (AMH) Anti-Müllerian Hormone at screening test Antral follicle count (AFC) less than 4 in both ovaries (at screening visit)

Exclusion criteria

Exclusion criteria: Body mass index (BMI) equal to or greater than 30 kg/m2 Any anatomical abnormalities in the uterus that prevent implantation and growth of the embryo, such as severe adenomyosis and Asherman syndrome. Severe endometriosis (stage 4). The patient is taking chemotherapy or strong anti-inflammatory drugs for underlying diseases. Known chromosomal or genetic abnormalities that cause a high-risk disorder in the child. Uncontrolled diabetes. The presence of severe male factor infertility, such as azoospermia

Design outcomes

Primary

Measure	Time frame
Safety of intraovarian injection of 50, 100 micrograms/ml of exosomes derived from placental mesenchymal stem cells. Timepoint: At the beginning of the study (before the intervention), 3, 7 and between 30- 60 days after the intervention. Method of measurement: Blood tests and ultrasound.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMohmmad vasei

Tehran University of Medical Sciences

mvasei@tums.ac.ir+98 21 8490 1000

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Jun 11, 2026