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Effect of astaxanthin on autophagy in infertile women with polycystic ovary syndrome

Effect of Astaxanthin on Ovarian Granulosa Cells Autophagy via the AMPK Signaling Pathway, in Infertile Women with Polycystic Ovarian Syndrome undergoing ART; a Triple Blind Randomized Clinical Trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20231028059882N1
Enrollment
50
Registered
2023-11-17
Start date
2023-11-22
Completion date
Unknown
Last updated
2025-01-08

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

Conditions

Polycystic Ovarian Syndrome. Polycystic ovarian syndrome

Interventions

Intervention 1: Intervention group: 25 eligible patients will receive 12 mg of astaxanthin (AstaZine®, from BGG) daily (one 4 mg capsule, every 8 hours) for 6 weeks until the day before the ovarian pu

Sponsors

Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 40 Years

Inclusion criteria

Inclusion criteria: Aged between 18 to 40 years old Body mass index (BMI): 20-30 Polycystic ovary syndrome (PCOS) diagnosis based on the Rotterdam criteria Assisted reproductive technology (ART) candidate due to anovulatory infertility Controlled ovulation stimulation (COS) by GnRH-Antagonist protocol

Exclusion criteria

Exclusion criteria: Pregnancy or abortion during last year before the start of the study History of other endocrinopathies such as adrenal hyperplasia, androgen-secreting tumors, hyperprolactinemia, thyroid dysfunction, diabetes, or impaired glucose tolerance Coexistence of other causes of infertility (severe male factor, tubal factor, uterine factor, endometriosis, Asherman syndrome, diminished ovarian reserves, etc.) Consumption of herbal or traditional medicine, antioxidant supplements, and vitamins within three months before the start of the study Taking ovulation-induction drugs, hormonal agents, and metformin within three months before the start of the study

Design outcomes

Primary

MeasureTime frame
Oocyte Maturity Rate (Number of mature oocytes (Metaphase II) : Total oocytes). Timepoint: 6 weeks after the start of the intervention (oocyte retrieval day). Method of measurement: Light microscope examination.;Number of high quality embryos. Timepoint: 3 days after intracytoplasmic sperm injection (ICSI). Method of measurement: Observation of male and female pronuclei (2PN) with light microscope.;Markers of AMPK-Autophagy signaling pathway (including AMPK, pAMPK, CL3-I, CL3-II, and SQSTM/P62 proteins and Beclin-1 and ATG7 genes). Timepoint: 6 weeks after the start of the intervention (oocyte retrieval day). Method of measurement: Western Blotting and realtime-qPCR.

Secondary

MeasureTime frame
Chemical Pregnancy Rate. Timepoint: Two weeks after embryo transfer. Method of measurement: BhCG test.;Clinical Pregnancy Rate. Timepoint: 6-8th week of gestational age. Method of measurement: observation of the gestational sac or heartbeat on ultrasound.;Miscarriage Rate. Timepoint: Early miscarriage until 12 weeks and late miscarriage until 20 weeks of gestation. Method of measurement: Ultrasound.;Ongoing Pregnancy Rate. Timepoint: until 20 weeks of gestation. Method of measurement: Ultrasound.;Apoptosis Markers in Granulosa Cells (including intact PARP and cleaved PARP proteins). Timepoint: 6 weeks after the start of the intervention (oocyte retrieval day). Method of measurement: Western Blotting.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactArezoo Maleki-Hajiagha

Tehran University of Medical Sciences

a-maleki@farabi.tums.ac.ir+98 21 8895 3008

Outcome results

None listed

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