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

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

Status
UNKNOWN
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05900661
Enrollment
300
Registered
2023-06-12
Start date
2023-07-30
Completion date
2023-09-30
Last updated
2023-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Poor Responders

Keywords

Cetrorelix, DHEA, somatotropin, myo inositol

Brief summary

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

Detailed description

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

DRUGmyo-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 .

DRUGSomatropin

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.

DRUGDehydroepiandrosterone

DHEA 50 mg twice per day for 12 weeks in the last group , NATROL UK.Ltd.

Sponsors

Beni-Suef University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
25 Years to 45 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Number and maturity of oocytes retrieved1 monthNumber and maturity of oocytes retrieved (M1/M2)

Secondary

MeasureTime frameDescription
chemical pregnancy rate1 monthhcg positive

Countries

Egypt

Contacts

Primary ContactSara A Salem, MD
sara_abdallah100@yahoo.com01272842226

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026