The effect of administering L-Carnitine to Clomiphene citrate stimulated cycles on conception rate and ovulation in infertile women with polycystic ovary syndrome

The effect of administering L-Carnitine to Clomiphene citrate stimulated cycles on ovulation and conception rate in infertile women with polycystic ovary syndrome: a randomized controlled clinical trial in Kabul.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20211204053267N1

Enrollment

Registered

2021-12-30

Start date

2022-01-21

Completion date

Unknown

Last updated

2022-01-11

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

Conditions

Infertility. Female infertility associated with anovulation

Interventions

Intervention 1: Intervention group: 16 people will be randomly selected, considering the sample size. L-Carnitine capsule 1000 mg from the American company called Pride Puritan's (2 capsules of 1 gram

Eligibility

Sex/Gender

Female

Age

20 Years to 35 Years

Inclusion criteria

Inclusion criteria: 20-35 years old women Primary infertility due to polycystic ovary syndrome diagnosed according to Rotterdam criteria by a gynaecologist Having regular vaginal intercourse in the last year

Exclusion criteria

Exclusion criteria: Infertility with other causes (such as male causes, tubular causes, etc.) Allergy to L-Carnitine Pregnancy or lactation Antimullerian hormone less than the normal range for age Having chronic diseases The body mass index (BMI) over30 Using other antioxidants or supplements Using insulin releasing drugs, lipid-lowering agents, antiepileptic drugs, drugs with effects on endocrine system and carbohydrate metabolism from 3 months before the start of the study

Design outcomes

Primary

Measure	Time frame
The primary outcome of the study will be chemical pregnancy rate which means that ß -HCG is more than 5 ml / ml, which is detected on the first day of the last menstrual cycle (LMP) at week 4-5 without the fetal heart and Or the pregnancy sac will be visible on ultrasound at 6-7 weeks. Timepoint: 3 times with intervals of 1 month. Method of measurement: Using a laboratory assay, ß -HCG more than mIU/mL based on the first day of the last menstrual cycle (LMP) at week 4-5.;The LH hormone will be checked on the eighteenth to the twenty-second day of cycle after drug administration, which is normal in the luteal phase (0.61 to 16.3 IU/L). If the level of this hormone is reported outside the range compared to the first test of this ovulation stimulation hormone from the laboratory, it will be considered as the lack of effect of this drug on the ovulation cycle. Timepoint: The LH levels will be checked on the eighteenth to the twenty-second day after the drug is administered. Method of measurement: The normal level of LH in the luteal phase is (0.61 to 16.3 IU/L).;Number of antral follicles in infertile women with polycystic ovary syndrome, on the twelfth day of the menstrual cycle to the 22nd day of the menstrual cycle after the intervention. Timepoint: For 3 months, after the twelfth day of the menstrual cycle, every two days, serially until the 22nd day of the menstrual cycle to evaluate the effect of the drug on the ovary and polycystic ovary syndrome will be performed using transvaginal ultrasound. Method of measurement: Using transvaginal ultrasound.;Clinical pregnancy in infertile women with polycystic ovary syndrome, after intervention. Timepoint: Monthly, 6-7 weeks from the first day of the last menstrual period for 3 months. Method of measurement: Finding the pregnancy sac and fetal heart using ultrasound at 6-7 weeks from the first day of the last menstrual period.;Antimullerian hormone levels in infertile women with polycystic ovary syndrome, on the third	—

Measure

Time frame

The primary outcome of the study will be chemical pregnancy rate which means that ß -HCG is more than 5 ml / ml, which is detected on the first day of the last menstrual cycle (LMP) at week 4-5 without the fetal heart and Or the pregnancy sac will be visible on ultrasound at 6-7 weeks. Timepoint: 3 times with intervals of 1 month. Method of measurement: Using a laboratory assay, ß -HCG more than mIU/mL based on the first day of the last menstrual cycle (LMP) at week 4-5.;The LH hormone will be checked on the eighteenth to the twenty-second day of cycle after drug administration, which is normal in the luteal phase (0.61 to 16.3 IU/L). If the level of this hormone is reported outside the range compared to the first test of this ovulation stimulation hormone from the laboratory, it will be considered as the lack of effect of this drug on the ovulation cycle. Timepoint: The LH levels will be checked on the eighteenth to the twenty-second day after the drug is administered. Method of measurement: The normal level of LH in the luteal phase is (0.61 to 16.3 IU/L).;Number of antral follicles in infertile women with polycystic ovary syndrome, on the twelfth day of the menstrual cycle to the 22nd day of the menstrual cycle after the intervention. Timepoint: For 3 months, after the twelfth day of the menstrual cycle, every two days, serially until the 22nd day of the menstrual cycle to evaluate the effect of the drug on the ovary and polycystic ovary syndrome will be performed using transvaginal ultrasound. Method of measurement: Using transvaginal ultrasound.;Clinical pregnancy in infertile women with polycystic ovary syndrome, after intervention. Timepoint: Monthly, 6-7 weeks from the first day of the last menstrual period for 3 months. Method of measurement: Finding the pregnancy sac and fetal heart using ultrasound at 6-7 weeks from the first day of the last menstrual period.;Antimullerian hormone levels in infertile women with polycystic ovary syndrome, on the third

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Countries

Afghanistan

Contacts

Public ContactShadab Shahali

Tarbiat Modares University

shadab.shahali@modares.ac.ir+98 21 8288 3811

Outcome results

None listed

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