Poor ovarian response. Other ovarian dysfunction: Poor ovarian response
Conditions
Interventions
Intervention 1: Intervention group: in this group patients, will receive 12 mg of astaxanthin capsules per day (in 3 capsules of 4mg a day) for 8 weeks. The appearance of placebo and astaxanthin capsu
Sponsors
Tehran University of Medical Sciences
Eligibility
Sex/Gender
Female
Age
36 Years to 41 Years
Inclusion criteria
Inclusion criteria: POR will be diagnosed based on PSEIDON: (i) age > 35 years, (ii) anti-Mullerian hormone (AMH) < 1.2 ng/mL or antral follicle count (AFC) < 5 The couple should be a candidate for ICSI
Exclusion criteria
Exclusion criteria: including spontaneous pregnancy, history of ovarian surgery, autoimmune or endocrine disease (diabetes, thyroid dysfunction, presence of anti-thyroid antibody or polycystic ovary), hyperprolactinemia, severe endometriosis (stages III and IV based on AFS-rAFS classification of endometriosis), recurrent Spontaneous miscarriage, ovarian tumor, chromosomal defect, uterine disorder, more than 3 previous IVF cycles, severe male factor infertility (especially non-obstructive azoospermia), history of taking drugs that affect ovarian function such as steroids and OCP. Also, people who have used antioxidant supplements, vitamins or drugs affecting the hormonal profile 3 months before the start of the plan will not be included in the plan. have any history of male factor infertility.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of MII oocytes. Timepoint: 8 weeks after the start of the intervention. Method of measurement: stereo microscope.;Number of retrieved oocytes. Timepoint: 8 weeks after the start of the intervention. Method of measurement: ????????? ??????.;Oocyte maturity rate (MII %). Timepoint: 8 weeks after the start of the intervention. Method of measurement: ????????? ??????.;Total gonadotrophin doses. Timepoint: During the ovarian stimulation cycle. Method of measurement: The prescribed medication dosage is reported in IU (International Units).;RFSH doses. Timepoint: During the ovarian stimulation cycle. Method of measurement: The prescribed medication dosage is reported in IU (International Units).;HMG doses. Timepoint: During the ovarian stimulation cycle. Method of measurement: The prescribed medication dosage is reported in IU (International Units).;Number of embryos. Timepoint: 8 weeks and 3 days after the start of the intervention. Method of measurement: stereo microscope.;Quality of embryos. Timepoint: 8 weeks and 3 days after the start of the intervention. Method of measurement: stereo microscope.;Antral follicular count. Timepoint: before the start of the intervention and 8 weeks after the start of the intervention. Method of measurement: vaginal sonography.;Fertilization rate. Timepoint: 8 weeks and 1 day after the start of the intervention (1 day after oocyte pick up). Method of measurement: stereo microscope.;Chemical pregnancy rate. Timepoint: 14 days after embryo transfer. Method of measurement: beta-HCG blood test.;Clinical pregnancy rate. Timepoint: 6-8th week of gestational age. Method of measurement: pregnancies showing confirmed clinical markers on ultrasound (like gestational sac and heart rate).;Cycle cancellation rate. Timepoint: 8 weeks after the start of the intervention. Method of measurement: Percentage of cycles canceled before OPU per the number of started cycles.;Number of transferred embryos. Timepoint: after the embryo transfer. Method of | — |
Secondary
| Measure | Time frame |
|---|---|
| Malondialdehyde [MDA] levels in follicular fluid. Timepoint: 8 weeks after the start of the intervention. Method of measurement: ELISA Kit.;Superoxide dismutase [SOD] levels in follicular fluid. Timepoint: 8 weeks after the start of the intervention. Method of measurement: ELISA Kit.;Total antioxidant capacity [TAC] levels in follicular fluid. Timepoint: 8 weeks after the start of the intervention. Method of measurement: ELISA Kit.;Interleukin-6 [IL-6] levels in follicular fluid. Timepoint: 8 weeks after the start of the intervention. Method of measurement: ELISA Kit.;Interleukin-8 [IL-8] interleukin-6 [IL-6]. Timepoint: 8 weeks after the start of the intervention. Method of measurement: ELISA Kit.;Vascular endothelial growth factor [VEGF] interleukin-6 [IL-6]. Timepoint: 8 weeks after the start of the intervention. Method of measurement: ELISA Kit.;Cell-free DNA interleukin-6 [IL-6]. Timepoint: 8 weeks after the start of the intervention. Method of measurement: qPCR.;Malondialdehyde [MDA] levels in serum. Timepoint: before the start of the intervention and 8 weeks after the intervention. Method of measurement: ELISA Kit.;Superoxide dismutase [SOD] levels in serum. Timepoint: before the start of the intervention and 8 weeks after the intervention. Method of measurement: ELISA Kit.;Total antioxidant capacity [TAC] levels in serum. Timepoint: before the start of the intervention and 8 weeks after the intervention. Method of measurement: ELISA Kit.;Interleukin-6 [IL-6] levels in serum. Timepoint: before the start of the intervention and 8 weeks after the intervention. Method of measurement: ELISA Kit.;Interleukin-8 [IL-8] levels in serum. Timepoint: before the start of the intervention and 8 weeks after the intervention. Method of measurement: ELISA Kit.;Vascular endothelial growth factor [VEGF] levels in serum. Timepoint: before the start of the intervention and 8 weeks after the intervention. Method of measurement: ELISA Kit. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactFardin Amidi
Tehran University of Medical Sciences
Outcome results
None listed