Effect of Alpha-Lipoic Acid Supplementation on Polycystic Ovary Syndrome Clinical Outcome in Infertile Females Treated With Letrozole

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 35
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Egypt
Ain shams university
RECRUITING
Cairo
Ain shams university
RECRUITING
Cairo
Contact Information
Primary
Muoaz A. Sallam, Teaching assistance
Moaaz.ahmed22@pharma.asu.edu.eg
+0201102174081
Time Frame
Start Date: 2024-04-01
Estimated Completion Date: 2025-12-01
Participants
Target number of participants: 150
Treatments
Other: 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.
Experimental: 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
Sponsors
Leads: Ain Shams University

This content was sourced from clinicaltrials.gov