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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| myo-inositol | Experimental | myo-inositol (1gm capsules bd ) plus folic acid 400 mcg per day |
|
| melatonin | Experimental | melatonin 1 capsule every night orally before going to bed plus folic acid 400mcg per day |
|
| co-enzyme Q10 | Experimental | co-enzyme Q10 100mg per day plus folic acid 400 mcg per day |
|
| control group. | Placebo Comparator | will receive folic acid 400 mcg per day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Myoinositol | Drug | an enzymatic isoform of inositol and belongs to the vitamin B complex family |
|
| Measure | Description | Time Frame |
|---|---|---|
| pregnancy | serum HCG positive | 1 month of induction for ICSI trial |
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Inclusion Criteria:
Infertile women who have one of the criteria of poor ovarian response as follows;
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sara S Sara Salem, MD | Contact | +201272842226 | sara_abdallah100@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Sara A Salem, MD | Beni-Suef University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beni-suef university Hospital | Banī Suwayf | 62511 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41800295 | Derived | Abdelrahman MA, Gamal M, Salem SA, Ibrahim ARN, Rabea H. Coenzyme Q10 Impact on Ovarian Reserve Measures and the Intra-Cytoplasmic Sperm Injection (ICSI) Outcomes in Women with Poor Ovarian Response: A Randomized Controlled Study. Drug Des Devel Ther. 2026 Mar 2;20:583321. doi: 10.2147/DDDT.S583321. eCollection 2026. |
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| ID | Term |
|---|---|
| D007294 | Inositol |
| C024989 | coenzyme Q10 |
| D008550 | Melatonin |
| D005492 | Folic Acid |
| ID | Term |
|---|---|
| D013402 | Sugar Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D002241 | Carbohydrates |
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| Co-Enzyme Q10 | Drug | a lipid-soluble quinone, acting as an effective antioxidant, |
|
|
| Melatonin | Drug | an indoleamine with low molecular weight that is synthesized by different cells and organs in the body. More importantly, melatonin is an outstanding antioxidant |
|
| Folic acid | Drug | control |
|
|
| D014363 |
| Tryptamines |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D011622 | Pterins |
| D011621 | Pteridines |