A Phase 3 interventional study of Myoinositol and Co-Enzyme Q10 in IVF, sponsored by Beni-Suef University. Not yet recruiting at 1 site in Egypt. Open to female participants aged 20 Years to 40 Years. Per ClinicalTrials.gov, last updated 2024-05-08.
Sponsored by Beni-Suef University · Phase 3, Interventional, and Treatment
To evaluate the role of Myo-inositol, melatonin and co-enzyme Q10 on ovarian reserve parameters and ICSI outcome in poor ovarian responder
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 (AFC),hormonal 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 0.25Mg/d, Merck Serono, Germany) 0.25 mg/day 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
Beni-Suef University is the lead sponsor of 333 studies on the registry; 116 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Infertile women who have one of the criteria of poor ovarian response as follows;
Exclusion Criteria:
myo-inositol (1gm capsules bd ) plus folic acid 400 mcg per day
Drug: Myoinositol
melatonin 1 capsule every night orally before going to bed plus folic acid 400mcg per day
Drug: Melatonin
co-enzyme Q10 100mg per day plus folic acid 400 mcg per day
Drug: Co-Enzyme Q10
will receive folic acid 400 mcg per day
Drug: Folic acid
an enzymatic isoform of inositol and belongs to the vitamin B complex family
Also known as: femtonex, Viocyst
a lipid-soluble quinone, acting as an effective antioxidant,
Also known as: Co Q
an indoleamine with low molecular weight that is synthesized by different cells and organs in the body. More importantly, melatonin is an outstanding antioxidant
control
Also known as: folicap
pregnancy
serum HCG positive
Time frame: 1 month of induction for ICSI trial
Plan to share: No
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This study is not yet recruiting, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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Beni-Suef University