DRUG
myo-inositol
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 .
Status
Unknown
Phase
Phase 2 / Phase 3
Enrollment
300
Locations
1
Results
Not posted
Publications
0
Study summary
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.
Interventions
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 .
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.
DRUG
DHEA 50 mg twice per day for 12 weeks in the last group , NATROL UK.Ltd.
Timeline
First posted
Jun 12, 2023
Study start
Jul 30, 2023
Primary completion
Sep 30, 2023
Study completion
Sep 30, 2023
Results posted
Not reported
Registry updated
Jul 18, 2023
Outcomes
Number and maturity of oocytes retrieved
Time frame · 1 month
Number and maturity of oocytes retrieved (M1/M2)
chemical pregnancy rate
Time frame · 1 month
hcg positive
Eligibility
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: 1. Any endocrine or metabolic disorder such as polycystic ovary syndrome, 2. Hyperprolactinemia, diabetes and thyroid dysfunction. 3. Any pelvic pathology such as hydrosalpinx, uterine anomaly. 4. any male factor infertility such as Oligo-Astheno-Teratozoospermia (OAT) or Azoospermia.
Study locations
Egypt. Showing up to 24 locations stored in the fast local snapshot.
Beni-suef university Hospital
Banī Suwayf, Beni Suweif Governorate, Egypt
Publications
No PMID-linked publications were present in this registry snapshot.
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