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

NCT ID: NCT05900661

Last Updated: 2023-07-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-30
• Study Completion Date: 2023-09-30

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.

Conditions

Poor Responders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

myo-inositol

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

Group Type: EXPERIMENTAL

myo-inositol

Intervention Type: 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 .

Somatropin

Somatropin (4 IU for 1month), SEDICO ,6th of october .Egypt. 1 s.c injection every 3 days for at least 1 month.

Group Type: EXPERIMENTAL

Somatropin

Intervention Type: 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

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

Group Type: EXPERIMENTAL

Dehydroepiandrosterone

Intervention Type: DRUG

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

Interventions

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 .

Intervention Type: DRUG

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.

Intervention Type: DRUG

Dehydroepiandrosterone

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

Intervention Type: DRUG

Other Intervention Names

Inofolic; DHEA

Eligibility Criteria

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.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Beni-Suef University

OTHER

Sponsor Role: lead

Responsible Party

Sara Abdallah Mohamed Salem

Lecturer of Gynecology and obstetrics Faculty of medicine Beni-Suef University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Beni-Suef University

Role: PRINCIPAL_INVESTIGATOR

Faculty of Medicine Beni-Suef University

Locations

Beni-suef university Hospital

Banī Suwayf, Beni Suweif Governorate, Egypt

Countries

Egypt

Central Contacts

Sara A Salem, MD

Role: CONTACT

sara_abdallah100@yahoo.com

01272842226 ext. 02

Other Identifiers

poor ovarian responders

Identifier Type: -

Identifier Source: org_study_id