of Myo-inositol, Melatonin and Co-enzyme q10 on Ovarian Reserve

The Effect of Myo-inositol, Melatonin and Co-enzyme q10 on Ovarian Reserve Parameters and Intra-cytoplasmic Sperm Injection Outcomes in Patient With Poor Ovarian Reserve: an Open Label Randomized Clinical Trial

To evaluate the role of Myo-inositol, melatonin and co-enzyme Q10 on ovarian reserve parameters and ICSI outcome in poor ovarian responder

Study Overview

• Status: Not yet recruiting
• Conditions: IVF
• Intervention / Treatment: Drug: Myoinositol; Drug: Melatonin; Drug: Co-Enzyme Q10; Drug: Folic acid

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 day 2 to day 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 300-450 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): 200
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Sara S Sara Salem, MD; Phone Number: +201272842226; Email: sara_abdallah100@yahoo.com

Study Locations

• Egypt
  • Banī Suwayf, Egypt, 62511
    • Beni-Suef University Hospital

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

1. Any endocrine or metabolic disorder such as hyperprolactinemia, diabetes and thyroid dysfunction
2. Any pelvic pathology such as hydrosalpinx, uterine anomaly.
3. 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: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: myo-inositol; myo-inositol (1gm capsules bd ) plus folic acid 400 mcg per day	Drug: Myoinositol; an enzymatic isoform of inositol and belongs to the vitamin B complex family; Other Names: femtonex; Viocyst
Experimental: melatonin; melatonin 1 capsule every night orally before going to bed plus folic acid 400mcg per day	Drug: Melatonin; an indoleamine with low molecular weight that is synthesized by different cells and organs in the body. More importantly, melatonin is an outstanding antioxidant
Experimental: co-enzyme Q10; co-enzyme Q10 100mg per day plus folic acid 400 mcg per day	Drug: Co-Enzyme Q10; a lipid-soluble quinone, acting as an effective antioxidant,; Other Names: Co Q
Placebo Comparator: control group.; will receive folic acid 400 mcg per day	Drug: Folic acid; control; Other Names: folicap

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pregnancy	serum HCG positive	1 month of induction for ICSI trial

Collaborators and Investigators

• Sponsor: Beni-Suef University
• Investigators: Principal Investigator: Sara A Salem, MD, Beni-Suef University

Study record dates

Study Major Dates

• Study Start (Estimated): June 30, 2024
• Primary Completion (Estimated): December 30, 2024
• Study Completion (Estimated): December 30, 2024

Study Registration Dates

• First Submitted: May 4, 2024
• First Submitted That Met QC Criteria: May 4, 2024
• First Posted (Actual): May 8, 2024

Study Record Updates

• Last Update Posted (Actual): May 8, 2024
• Last Update Submitted That Met QC Criteria: May 4, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Melatonin; ovarian reserve; Myo-inositol; Co-enzyme q10
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Protective Agents; Micronutrients; Vitamins; Antioxidants; Vitamin B Complex; Hematinics; Melatonin; Folic Acid; Coenzyme Q10; Ubiquinone; Inositol
• Other Study ID Numbers: Co-enzyme q10

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