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.

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

Study Overview

• Status: Not yet recruiting
• Conditions: Poor Responders
• Intervention / Treatment: Drug: myo-inositol; Drug: Somatropin; Drug: Dehydroepiandrosterone

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.

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Sara A Salem, MD; Phone Number: 02 01272842226; Email: sara_abdallah100@yahoo.com

Study Locations

• Egypt
  • Beni Suef
    • Banī Suwayf, Beni Suef, Egypt, 62521
      • Beni-Suef University hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	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 .; Other Names: Inofolic
Experimental: Somatropin; Somatropin (4 IU for 1month), SEDICO ,6th of october .Egypt. 1 s.c injection every 3 days for at least 1 month.	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.
Experimental: Dehydroepiandrosterone; DHEA 50 mg twice per day for 12 weeks in the last group , NATROL UK.Ltd.	Drug: Dehydroepiandrosterone; DHEA 50 mg twice per day for 12 weeks in the last group , NATROL UK.Ltd.; Other Names: DHEA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number and maturity of oocytes retrieved	Number and maturity of oocytes retrieved (M1/M2)	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
chemical pregnancy rate	hcg positive	1 month

Collaborators and Investigators

• Sponsor: Beni-Suef University
• Investigators: Principal Investigator: Beni-Suef University, Faculty of Medicine Beni-Suef University

Study record dates

Study Major Dates

• Study Start (Estimated): July 30, 2023
• Primary Completion (Estimated): September 30, 2023
• Study Completion (Estimated): September 30, 2023

Study Registration Dates

• First Submitted: June 4, 2023
• First Submitted That Met QC Criteria: June 4, 2023
• First Posted (Actual): June 12, 2023

Study Record Updates

• Last Update Posted (Actual): July 18, 2023
• Last Update Submitted That Met QC Criteria: July 16, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: DHEA; Cetrorelix; somatotropin; myo inositol
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Immunologic Factors; Micronutrients; Adjuvants, Immunologic; Vitamins; Vitamin B Complex; Dehydroepiandrosterone; Inositol
• Other Study ID Numbers: poor ovarian responders

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No