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To evaulate the role of Myo-inositol, somatropin, DHEA on 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 D2 to 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 150-300 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 | will recive Inofolic (myo-inositol 600µgm + folic acid 0.2 mg) 2 capsules at the morning and 2 capsules at the evening on empty stomach for 12 weeks |
|
| Somatropin | Experimental | Somatropin (4 IU for 1month), SEDICO ,6th of october .Egypt. 1 s.c injection every 3 days for at least 1 month. |
|
| Dehydroepiandrosterone | Experimental | DHEA 50 mg twice per day for 12 weeks in the last group , NATROL UK.Ltd. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| myo-inositol | Drug | myo-inositol 600µgm + folic acid 0.2 mg) 2 capsules at the morning and 2 capsules at the evening on empty stomach for 12 weeks produced by a Lo.Li pharma international ,Rome.Italy . |
| Measure | Description | Time Frame |
|---|---|---|
| Number and maturity of oocytes retrieved | Number and maturity of oocytes retrieved (M1/M2) | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| chemical pregnancy rate | hcg positive | 1 month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sara A Salem, MD | Contact | 01272842226 | 02 | sara_abdallah100@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Beni-Suef University | Faculty of Medicine Beni-Suef University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beni-suef university Hospital | Banī Suwayf | Beni Suweif Governorate | 62521 | Egypt |
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| ID | Term |
|---|---|
| D007294 | Inositol |
| D019382 | Human Growth Hormone |
| D003687 | Dehydroepiandrosterone |
| ID | Term |
|---|---|
| D013402 | Sugar Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D002241 | Carbohydrates |
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|
| Somatropin | Drug | growth hormone 2:Somatropin (4 IU for 1month), SEDICO ,6th of october .Egypt. 1 s.c injection every 3 days for at least 1 month. |
|
| Dehydroepiandrosterone | Drug | DHEA 50 mg twice per day for 12 weeks in the last group , NATROL UK.Ltd. |
|
|
| D013006 |
| Growth Hormone |
| D010908 | Pituitary Hormones, Anterior |
| D010907 | Pituitary Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000737 | Androstenols |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D015068 | 17-Ketosteroids |
| D007664 | Ketosteroids |
| D000305 | Adrenal Cortex Hormones |
| D045165 | Testosterone Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |