The effects inofolic supplementation, probiotic and vitamin D in polycystic ovary syndrome women candidate for In Vitro fertilization

The effect of inofolic supplementation in combination with probiotics and vitamin D on ovarian response and metabolic profiles in women with polycystic ovary syndrome candidate for In Vitro Fertilization

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20130211012438N34

Enrollment

120

Registered

2023-01-23

Start date

2023-02-20

Completion date

Unknown

Last updated

2023-02-07

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

Conditions

Condition 1: Polycystic ovary syndrome. Condition 2: Infertility. Polycystic ovarian syndrome Female infertility

Interventions

Intervention 1: Intervention group 1: Inofolic Sachet

Inositol 2gr, twice a day(Teb mofid nikan,Alborz, Iran) plus probiotic Capsule

Lactobacillus acidophilus, Bifidobacterium bifidum, Bifidobacterium langum, Bifidobacterium lactis (1.8 ×109 CFU/capsule), One capsule per day( Takgene Zist ,Tehran, Iran) plus Vitamin D Capsule

4000 IU ,One capsule per day( Daana ,Tabriz ,Iran) for 8 weeks orally. Intervention 2: Intervention group 2: Inofolic Sachet

Inositol 2gr, twice a day(Teb mofid nikan, Alborz, Iran) plus probiotic Capsule

Lactobacillus acidophilus, Bifidobacterium bifidum, Bifidobacterium langum, Bifidobacterium lactis (1.8 ×109 CFU/capsule), One capsule per day( Takgene Zist ,Tehran, Iran) plus Vitamin D placebo (Daan

Inositol 2gr, twice a day(Teb mofid nikan ,Alborz,Tehran) plus Probiotic placebo

starch, One capsule per day( Takgene Zist ,Tehran, Iran) plus Vitamin D Capsule

4000 IU ,One capsule per day( Daana ,Tabriz ,Iran) for 8 weeks orally. Intervention 4: Control group: Inofolic Sachet

Inositol 2gr, twice a day(Teb mofid nikan ,Alborz, Iran) plus Probiotic placebo

starch ( Takgene Zist ,Tehran, Iran), One capsule per day plus Vitamin D placebo (Daana ,Tabriz,Iran), One capsule per day for 8 weeks orally.

Eligibility

Sex/Gender

Female

Age

30 Years to 45 Years

Inclusion criteria

Inclusion criteria: Women with Polycystic Ovary Syndrome (PCOS) according to the Rotterdam criteria In Vitro Fertilization (IVF) candidate Age 45-30 years No smoking Male reproductive health

Exclusion criteria

Exclusion criteria: Uncontrolled thyroid disorder Diagnosis of severe depression

Design outcomes

Primary

Measure	Time frame
Anti Mullerian Hormone (AMH). Timepoint: Before the intervention and after 8 weeks from the start of the intervention. Method of measurement: ELISA.;High Sensitivity- C Reactive Protein (hs-CRP). Timepoint: Before the intervention and after 8 weeks from the start of the intervention. Method of measurement: ELISA.;Beck score. Timepoint: Before the intervention and after 8 weeks from the start of the intervention. Method of measurement: Beck questionnaire.	—

Measure

Time frame

Anti Mullerian Hormone (AMH). Timepoint: Before the intervention and after 8 weeks from the start of the intervention. Method of measurement: ELISA.;High Sensitivity- C Reactive Protein (hs-CRP). Timepoint: Before the intervention and after 8 weeks from the start of the intervention. Method of measurement: ELISA.;Beck score. Timepoint: Before the intervention and after 8 weeks from the start of the intervention. Method of measurement: Beck questionnaire.

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Secondary

Measure	Time frame
Fasting plasma glucose. Timepoint: Before the intervention and after 8 weeks from the start of the intervention. Method of measurement: Enzymatic Kits with BT-3000.;Insulin. Timepoint: Before the intervention and after 8 weeks from the start of the intervention. Method of measurement: ELISA.;HOMA-IR. Timepoint: Before the intervention and after 8 weeks from the start of the intervention. Method of measurement: Calculated with standard formula.;Nitric oxide. Timepoint: Before the intervention and after 8 weeks from the start of the intervention. Method of measurement: Photospectrometry.;Total Anti Oxidant (TAC). Timepoint: Before the intervention and after 8 weeks from the start of the intervention. Method of measurement: Photospectrometry.;Glutathion. Timepoint: Before the intervention and after 8 weeks from the start of the intervention. Method of measurement: Photospectrometry.;Malondialdehyde. Timepoint: Before the intervention and after 8 weeks from the start of the intervention. Method of measurement: Photospectrometry.;Peroxisome proliferator-activated receptor gamma (PPAR-? ) gene expression. Timepoint: Before the intervention and after 8 weeks from the start of the intervention. Method of measurement: RT-PCR.;Low Density Lipoprotein Receptor (LDLR) gene expression. Timepoint: Before the intervention and after 8 weeks from the start of the intervention. Method of measurement: RT-PCR.;Tumour necrosis factor a (TNFa) gene expression. Timepoint: Before the intervention and after 8 weeks from the start of the intervention. Method of measurement: RT-PCR.;Interferon gamma (IFN-?) gene expression. Timepoint: Before the intervention and after 8 weeks from the start of the intervention. Method of measurement: RT-PCR.;Vascular endothelial growth factor (VEGF) gene expression. Timepoint: Before the intervention and after 8 weeks from the start of the intervention. Method of measurement: RT-PCR.;Anxiety. Timepoint: Before the intervention and after 8 weeks from the start	—

Measure

Time frame

Fasting plasma glucose. Timepoint: Before the intervention and after 8 weeks from the start of the intervention. Method of measurement: Enzymatic Kits with BT-3000.;Insulin. Timepoint: Before the intervention and after 8 weeks from the start of the intervention. Method of measurement: ELISA.;HOMA-IR. Timepoint: Before the intervention and after 8 weeks from the start of the intervention. Method of measurement: Calculated with standard formula.;Nitric oxide. Timepoint: Before the intervention and after 8 weeks from the start of the intervention. Method of measurement: Photospectrometry.;Total Anti Oxidant (TAC). Timepoint: Before the intervention and after 8 weeks from the start of the intervention. Method of measurement: Photospectrometry.;Glutathion. Timepoint: Before the intervention and after 8 weeks from the start of the intervention. Method of measurement: Photospectrometry.;Malondialdehyde. Timepoint: Before the intervention and after 8 weeks from the start of the intervention. Method of measurement: Photospectrometry.;Peroxisome proliferator-activated receptor gamma (PPAR-? ) gene expression. Timepoint: Before the intervention and after 8 weeks from the start of the intervention. Method of measurement: RT-PCR.;Low Density Lipoprotein Receptor (LDLR) gene expression. Timepoint: Before the intervention and after 8 weeks from the start of the intervention. Method of measurement: RT-PCR.;Tumour necrosis factor a (TNFa) gene expression. Timepoint: Before the intervention and after 8 weeks from the start of the intervention. Method of measurement: RT-PCR.;Interferon gamma (IFN-?) gene expression. Timepoint: Before the intervention and after 8 weeks from the start of the intervention. Method of measurement: RT-PCR.;Vascular endothelial growth factor (VEGF) gene expression. Timepoint: Before the intervention and after 8 weeks from the start of the intervention. Method of measurement: RT-PCR.;Anxiety. Timepoint: Before the intervention and after 8 weeks from the start

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactMohsen Taghizadeh

Kashan University of Medical Sciences

taghizadeh_m@kaums.ac.ir+98 31 5533 3213

Outcome results

None listed

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