The Effect of Myo-inositol, Somatropin, and DHEA on Poor Ovarian Responders

Study Overview
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Brief Summary
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To evaulate the role of Myo-inositol, somatropin, DHEA on ICSI outcome in poor ovarian responder

Detailed Description
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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.

Official Title
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The Effect of Myo-inositol, Somatropin, and DHEA on Poor Ovarian Responders Undergoing ICSI : an Open Label Randomized Clinical Trial.

Conditions
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Poor Responders

Intervention / Treatment
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* Drug: myo-inositol
* Drug: Somatropin
* Drug: Dehydroepiandrosterone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1-Infertile women who have one of the criteria of poor ovarian response as follows ; Antral follicle count less than 7 Anti-Mullerian hormone level Less than 1.2 ng/ml 2- females with body mass index (BMI) from 19-25 Exclusion Criteria: Any endocrine or metabolic disorder such as polycystic ovary syndrome, Hyperprolactinemia, diabetes and thyroid dysfunction. Any pelvic pathology such as hydrosalpinx, uterine anomaly. any male factor infertility such as Oligo-Astheno-Teratozoospermia (OAT) or Azoospermia.

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: myo-inositol<br>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 | Drug: myo-inositol<br>* 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 .<br>* Other names: Inofolic;|
| Experimental: Somatropin<br>Somatropin (4 IU for 1month), SEDICO ,6th of october .Egypt. 1 s.c injection every 3 days for at least 1 month. | Drug: Somatropin<br>* 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.<br>|
| Experimental: Dehydroepiandrosterone<br>DHEA 50 mg twice per day for 12 weeks in the last group , NATROL UK.Ltd. | Drug: Dehydroepiandrosterone<br>* DHEA 50 mg twice per day for 12 weeks in the last group , NATROL UK.Ltd.<br>* Other names: DHEA;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number and maturity of oocytes retrieved | Number and maturity of oocytes retrieved (M1/M2) | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| chemical pregnancy rate | hcg positive | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cetrorelix, DHEA, somatotropin, myo inositol