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

NCT05900661 | Unknown Phase 2

• 1 other identifier: poor ovarian responders
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Poor Responders

Keywords

Cetrorelix; DHEA; somatotropin; myo inositol

Outcome Measures

Primary Outcomes (1)

• Number and maturity of oocytes retrieved

  Number and maturity of oocytes retrieved (M1/M2)

  1 month

Secondary Outcomes (1)

• chemical pregnancy rate

  1 month

Study Arms (3)

myo-inositol

EXPERIMENTAL

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

Somatropin

EXPERIMENTAL

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

Drug: Somatropin

Dehydroepiandrosterone

EXPERIMENTAL

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

Drug: Dehydroepiandrosterone

Interventions

myo-inositol 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 .

Also known as: Inofolic

myo-inositol

Somatropin 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.

Somatropin

Dehydroepiandrosterone DRUG

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

Also known as: DHEA

Dehydroepiandrosterone

Eligibility Criteria

• Age: 25 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beni-Suef University: lead

Study Sites (1)

Beni-suef university Hospital

Banī Suwayf, Beni Suweif Governorate, 62521, Egypt

Location

MeSH Terms

Interventions

Inositol; Human Growth Hormone; Dehydroepiandrosterone

Intervention Hierarchy (Ancestors)

Sugar Alcohols; Alcohols; Organic Chemicals; Carbohydrates; Growth Hormone; Pituitary Hormones, Anterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Androstenols; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; 17-Ketosteroids; Ketosteroids; Adrenal Cortex Hormones; Testosterone Congeners; Gonadal Steroid Hormones; Gonadal Hormones

Study Officials

• Beni-Suef University

  Faculty of Medicine Beni-Suef University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sara A Salem, MD

CONTACT

01272842226; sara_abdallah100@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Gynecology and obstetrics Faculty of medicine Beni-Suef University

Study Record Dates

• First Submitted: June 4, 2023
• First Posted: June 12, 2023
• Study Start: July 30, 2023
• Primary Completion: September 30, 2023
• Study Completion: September 30, 2023
• Last Updated: July 18, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)