Ignite Creation Date:
2024-05-11 @ 8:30 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06405204
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-08
First Post:
2024-05-04
Brief Title:
of Myo-inositol Melatonin and Co-enzyme q10 on Ovarian Reserve
Sponsor:
Beni-Suef University
Organization:
Beni-Suef University
Study Overview
Official Title:
The Effect of Myo-inositol Melatonin and Co-enzyme q10 on Ovarian Reserve Parameters and Intra-cytoplasmic Sperm Injection Outcomes in Patient With Poor Ovarian Reserve an Open Label Randomized Clinical Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
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:
To evaluate the role of Myo-inositol melatonin and co-enzyme Q10 on ovarian reserve parameters and ICSI outcome in poor ovarian responder
Detailed Description:
Each patient will be subjected to
Full history taking Systematic clinical examination to assess the general condition body mass index BMI and local pelvic physical findings and AFC by trans-vaginal ultrasound on day 2 to day 3 of menstruation Routine labs as CBC liver kidney functions to exclude general disease as a contraindication for induction or pregnancy
Blood sample will be obtained for assessment of basal serum levels of FSH LH E2 on days 2- 3 of the cycle PRL AMH and TSH Ovarian Stimulation The patients will begin injections of recombinant FSH rFSH Gonal-F Merck- Serono Italy from day 2-3 of menstruation with daily dose of 300-450 IU adjusted according to individual conditions on the basis of the antral follicle count AFChormonal profile age body mass index BMI and previous ovarian response according to the standard operating procedures of the center For pituitary suppression the patients will receive GnRH antagonist Cetrorelix CETROTIDE 025Mgd Merck Serono Germany 025 mgday subcutaneously from day 6 of induction until trigger day The serum LH estradiol levels as well as number and size of follicles will be monitored every two days starting from stimulation day 6 until the day of hCG injection
Full history taking Systematic clinical examination to assess the general condition body mass index BMI and local pelvic physical findings and AFC by trans-vaginal ultrasound on day 2 to day 3 of menstruation Routine labs as CBC liver kidney functions to exclude general disease as a contraindication for induction or pregnancy
Blood sample will be obtained for assessment of basal serum levels of FSH LH E2 on days 2- 3 of the cycle PRL AMH and TSH Ovarian Stimulation The patients will begin injections of recombinant FSH rFSH Gonal-F Merck- Serono Italy from day 2-3 of menstruation with daily dose of 300-450 IU adjusted according to individual conditions on the basis of the antral follicle count AFChormonal profile age body mass index BMI and previous ovarian response according to the standard operating procedures of the center For pituitary suppression the patients will receive GnRH antagonist Cetrorelix CETROTIDE 025Mgd Merck Serono Germany 025 mgday subcutaneously from day 6 of induction until trigger day The serum LH estradiol levels as well as number and size of follicles will be monitored every two days starting from stimulation day 6 until the day of hCG injection
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?:
None
Is an FDA AA801 Violation?:
None