Effect of Alpha-Lipoic Acid Supplementation on Polycystic Ovary Syndrome Clinical Outcome in Infertile Females Treated With Letrozole
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- The primary outcome is cumulative ovulation rate
研究概览
简要总结
This research study aims to investigate the effect of adding Alpha lipoic acid (ALA) supplement to letrozole treatment in infertile women with polycystic ovary syndrome (PCOS). The study will include 150 PCOS participants seeking fertility treatment. They will be randomly divided into two groups - control and intervention. Both groups will receive standard PCOS care including lifestyle counseling. The control group will be treated with letrozole only. The dose will start at (2.5 mg) for 5 days and can increase up to (7.5 mg) based on response. The intervention group will take ALA supplements along with letrozole treatment. ALA tablets (600mg) will be given three times daily starting from day 3 of the menstrual cycle till human chorionic gonadotropin (HCG) injection day. Letrozole dose for the intervention group will also follow the same incremental protocol as the control group. Patient monitoring will involve trans-vaginal ultrasound scans on certain cycle days to check follicle growth and the thickness of uterus lining. Once a follicle reaches 18mm in size, an intramuscular HCG injection will be given. Couples will be asked to have intercourse 36 hours after the injection.
Pregnancy will be tested two weeks later if menstruation does not occur. Metabolic, hormonal, and ultrasound parameters will be recorded at baseline and follow-ups. All adverse effects of the treatment will be noted. The study period will be a maximum of 3 treatment cycles or untill pregnancy is achieved. Outcome measures include ovulation and pregnancy rates. The effect of ALA on metabolic parameters (fasting glucose, fasting insulin, BMI and HOMA-IR), hormone levels (mid-luteal progesterone and serum estradiol), and follicular growth will also be assessed. Proper sample size and randomization methods will be followed. A Statistical analysis of collected data will help determine if ALA has additional benefits when combined with letrozole for PCOS fertility treatment. Finally, the results will be statistically analyzed. Statistical analysis will be done using the SPSS statistical software package.
详细描述
Eligible participants will be randomly allocated to the control group or the intervention group with a ratio of 1:1 after obtaining informed consent.
The two study groups will be as follows:
Control group: this group will include 75 PCOS participants who will receive the standard treatment letrozole and the other commonly provided PCOS care (lifestyle modification, diet and exercise education, any other non-pharmacological method of management) according to the PCOS guidelines.
Treatment with letrozole will begin after the baseline visit, and for three cycles, the administration will start after a spontaneous or progesterone-induced menstruation. In the first cycle, "2.5" mg letrozole will be taken for 5 days starting from day 3 to 7 of the menses, if no pregnancy was detected, letrozole dose will be increased to "5 mg" in the next cycle, and finally, "7.5 mg" letrozole will be administered during the third cycle if the patient is still unable to conceive.
Interventional group: this will include 75 PCOS participants who will receive the standard treatment as letrozole with the same schedule as the control group and the other commonly provided PCOS care as previously described in addition to ALA, (Thiotacid®, EVAPHARMA, Egypt) in a dose of one tablet "600 mg" three times per day Each patient in the test group will start the ALA from day 3 of the menstrual period, then daily until the day of human chorionic gonadotropin (HCG) injection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patient aged 18-35
- •Willing to conceive
- •PCOS, diagnosed according to the revised 2003 Rotterdam consensus criteria. " Oligo- or anovulation secondary to PCOS and at least one of the remaining two criteria: hyperandrogenism or polycystic ovarian morphology on ultrasound .
- •Anovulation and/or infertility ≥ 1 year.
- •At least one patent fallopian tube
- •Normal uterine cavity
- •Male partner with sperm concentration of at least 14 million/mL in at least one ejaculate.
排除标准
- •Other causes for the infertility (male factor, tubal factor).
- •Intake of hormonal or other drugs that can potentially influence the ovulation.
- •Causes of anovulation or hyperandrogenism other than PCOS such as uncontrolled thyroid dysfunction or hyperprolactinemia.
- •Contraindication to pregnancy
- •Myo-inositol use < 3 months prior to study enrollment
- •Concomitant metformin use. Previous use is allowed with last use at least 6 weeks prior to randomization.
研究组 & 干预措施
Control
This group will include 75 PCOS participants who will receive the standard treatment letrozole and the other commonly provided PCOS care (lifestyle modification, diet and exercise education, any other non-pharmacological method of management) according to the PCOS guidelines .Treatment with letrozole will begin after the baseline visit and for three cycles.
干预措施: Letrozole (Drug)
Intervention
this will include 75 PCOS participants who will receive the standard treatment as letrozole with the same schedule of the control group and the other commonly provided PCOS care as previously described in addition to ALA, (Thiotacid®, EVAPHARMA, Egypt) in a dose of one tablet "600 mg" three times per day Each patient in the test group will start the ALA from day 3 of the menstrual period then daily until the day of human chorionic gonadotropin (HCG) injection
干预措施: Alpha lipoic acid (Drug)
Intervention
this will include 75 PCOS participants who will receive the standard treatment as letrozole with the same schedule of the control group and the other commonly provided PCOS care as previously described in addition to ALA, (Thiotacid®, EVAPHARMA, Egypt) in a dose of one tablet "600 mg" three times per day Each patient in the test group will start the ALA from day 3 of the menstrual period then daily until the day of human chorionic gonadotropin (HCG) injection
干预措施: Letrozole (Drug)
结局指标
主要结局
The primary outcome is cumulative ovulation rate
时间窗: 1 year
which is defined as the proportion of cycles in which ovulation occurred in the whole follow-up period.
The primary outcome is cumulative ovulation rate
时间窗: 3 months
which is defined as the proportion of cycles in which ovulation occurred in the whole follow-up period.
次要结局
- mid-luteal progesterone(1 year)
- BMI in kg/m^2(1 year)
- The clinical pregnancy rate(1 year)
- HOMA-IR(1 year)
- number of dominant follicles (≥18 mm)(1 year)
- endometrial thickness(1 year)
- size of follicles(1 year)
- serum estradiol(1 year)
- size of follicles(3 months)
- The clinical pregnancy rate(3 months)
- BMI in kg/m^2(3 months)
- HOMA-IR(3 months)
- serum estradiol(3 months)
- mid-luteal progesterone(3 months)
- number of dominant follicles (≥18 mm)(3 months)
- endometrial thickness(3 months)