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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05900661
Other study ID # poor ovarian responders
Secondary ID
Status Not yet recruiting
Phase Phase 2/Phase 3
First received
Last updated
Start date July 30, 2023
Est. completion date September 30, 2023

Study information

Verified date July 2023
Source Beni-Suef University
Contact Sara A Salem, MD
Phone 01272842226
Email sara_abdallah100@yahoo.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 300
Est. completion date September 30, 2023
Est. primary completion date September 30, 2023
Accepts healthy volunteers No
Gender Female
Age group 25 Years to 45 Years
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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Egypt Beni-suef university Hospital Bani Suwayf Beni Suef

Sponsors (1)

Lead Sponsor Collaborator
Beni-Suef University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number and maturity of oocytes retrieved Number and maturity of oocytes retrieved (M1/M2) 1 month
Secondary chemical pregnancy rate hcg positive 1 month
See also
  Status Clinical Trial Phase
Completed NCT03438812 - Dehydroepiandrosterone Maintain Mitochondrial Quality of Cumulus Cells in Poor Ovarian Responders N/A
Completed NCT02158689 - Comparison of Treatment Modalities in Poor Responders Undergoing IVF N/A
Recruiting NCT04487925 - Controlled Ovarian Stimulation Versus Modified Natural Cycles in Poor Responders Phase 4
Recruiting NCT02201914 - Clomiphene Citrate Plus Gonadotropins and GnRH Antagonist Versus Flexible GnRH Antagonist Protocol Versus Microdose GnRH Agonist Protocol in Poor Responders Undergoing IVF Phase 4