Ignite Creation Date:
2024-05-19 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06418347
Status:
RECRUITING
Last Update Posted:
2024-05-17
First Post:
2024-03-29
Brief Title:
Effect of ALA Combined With Letrozole on Polycystic Ovary Syndrome Clinical Outcome in Infertile Females
Sponsor:
Ain Shams University
Organization:
Ain Shams University
Study Overview
Official Title:
Effect of Alpha-Lipoic Acid Supplementation on Polycystic Ovary Syndrome Clinical Outcome in Infertile Females Treated With Letrozole
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 25 mg for 5 days and can increase up to 75 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
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
Detailed Description:
Eligible participants will be randomly allocated to the control group or the intervention group with a ratio of 11 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 25 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 75 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
Baseline assessment
After enrollment baseline data and demographics will be obtained from each participant including
Age and body mass index will be calculated in Kgm2
Serum FSH LH TSH prolactin androgens including free and total testosterone and SHBG
Ultrasound measurements including antral-follicles count and detection of Polycystic ovaries defined as either 12 or more follicles measuring 2 to 9 mm in diameter or an increased ovarian volume 10 cm3
Menstrual cyclicity presence of first degree relatives with diabetes mellitus smoking status comorbidities medication history
All subjects will be educated about their diet and physical activity and they will be asked not to start any new medications during the study without informing the principal investigator
Patients monitoring and follow-up All the participants included in the study after a spontaneous or progesterone-induced menstrual cycle will be randomly assigned to either Control group or Interventional group and will be monitored by trans-vaginal ultrasound to assess follicular diameter and endometrial thickness on the 10th day of the cycle then on 12th 14th and the 20th days of the cycle for assessment of dominant follicle 18 mm on TVUS The number of dominant follicles and the endometrial thickness will be documented for each menstrual cycle
When at least one dominant follicle is detected participants will receive an intramuscular injection of 10 000 IU human chorionic gonadotropin HCG Choriomon IBSA
An HCG injection will be given when at least one follicle measuring at least 18 mm is observed
Ovulation will also be confirmed by the evaluation of serum progesterone each cycle between cycle days 20-22 5 ngmL and the test will be repeated 1 week later if the initial progesterone level is below the threshold to confirm ovulation
Couples will be instructed to have timed intercourse 36 hours after the HCG injection
Serum HCG will be determined 2 weeks after HCG injection in the absence of menstruation for the detection of pregnancy
Pregnant women will be required to stop all medication
Patients who do not have any dominant follicles will start a new ovulation induction cycle in the following month
Treatment of the next cycle will start if menses occurs either spontaneously or by induction The first day of the menses is considered the first day of the cycle and this is repeated for up to a total of 3 treatment cycles
For those who fail to achieve a dominant follicle alpha lipoic acid will be stopped and restarted in the next cycle as before
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 25 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 75 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
Baseline assessment
After enrollment baseline data and demographics will be obtained from each participant including
Age and body mass index will be calculated in Kgm2
Serum FSH LH TSH prolactin androgens including free and total testosterone and SHBG
Ultrasound measurements including antral-follicles count and detection of Polycystic ovaries defined as either 12 or more follicles measuring 2 to 9 mm in diameter or an increased ovarian volume 10 cm3
Menstrual cyclicity presence of first degree relatives with diabetes mellitus smoking status comorbidities medication history
All subjects will be educated about their diet and physical activity and they will be asked not to start any new medications during the study without informing the principal investigator
Patients monitoring and follow-up All the participants included in the study after a spontaneous or progesterone-induced menstrual cycle will be randomly assigned to either Control group or Interventional group and will be monitored by trans-vaginal ultrasound to assess follicular diameter and endometrial thickness on the 10th day of the cycle then on 12th 14th and the 20th days of the cycle for assessment of dominant follicle 18 mm on TVUS The number of dominant follicles and the endometrial thickness will be documented for each menstrual cycle
When at least one dominant follicle is detected participants will receive an intramuscular injection of 10 000 IU human chorionic gonadotropin HCG Choriomon IBSA
An HCG injection will be given when at least one follicle measuring at least 18 mm is observed
Ovulation will also be confirmed by the evaluation of serum progesterone each cycle between cycle days 20-22 5 ngmL and the test will be repeated 1 week later if the initial progesterone level is below the threshold to confirm ovulation
Couples will be instructed to have timed intercourse 36 hours after the HCG injection
Serum HCG will be determined 2 weeks after HCG injection in the absence of menstruation for the detection of pregnancy
Pregnant women will be required to stop all medication
Patients who do not have any dominant follicles will start a new ovulation induction cycle in the following month
Treatment of the next cycle will start if menses occurs either spontaneously or by induction The first day of the menses is considered the first day of the cycle and this is repeated for up to a total of 3 treatment cycles
For those who fail to achieve a dominant follicle alpha lipoic acid will be stopped and restarted in the next cycle as before
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None