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

NCT06405204 | Not Yet Recruiting Phase 3

• 1 other identifier: Co-enzyme q10
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

IVF

Keywords

Myo-inositol; Melatonin; Co-enzyme q10; ovarian reserve

Outcome Measures

Primary Outcomes (1)

• pregnancy

  serum HCG positive

  1 month of induction for ICSI trial

Study Arms (4)

myo-inositol

EXPERIMENTAL

myo-inositol (1gm capsules bd ) plus folic acid 400 mcg per day

Drug: Myoinositol

melatonin

EXPERIMENTAL

melatonin 1 capsule every night orally before going to bed plus folic acid 400mcg per day

Drug: Melatonin

co-enzyme Q10

EXPERIMENTAL

co-enzyme Q10 100mg per day plus folic acid 400 mcg per day

Drug: Co-Enzyme Q10

control group.

PLACEBO COMPARATOR

will receive folic acid 400 mcg per day

Drug: Folic acid

Interventions

Myoinositol DRUG

an enzymatic isoform of inositol and belongs to the vitamin B complex family

Also known as: femtonex, Viocyst

myo-inositol

Co-Enzyme Q10 DRUG

a lipid-soluble quinone, acting as an effective antioxidant,

Also known as: Co Q

co-enzyme Q10

Melatonin DRUG

an indoleamine with low molecular weight that is synthesized by different cells and organs in the body. More importantly, melatonin is an outstanding antioxidant

melatonin

Folic acid DRUG

control

Also known as: folicap

control group.

Eligibility Criteria

• Age: 20 Years - 40 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

You may not qualify if:

• Any endocrine or metabolic disorder such as 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, 62511, Egypt

Location

MeSH Terms

Interventions

Inositol; coenzyme Q10; Melatonin; Folic Acid

Intervention Hierarchy (Ancestors)

Sugar Alcohols; Alcohols; Organic Chemicals; Carbohydrates; Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pterins; Pteridines

Study Officials

• Sara A Salem, MD

  Beni-Suef University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sara S Sara Salem, MD

CONTACT

+201272842226; sara_abdallah100@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principle investigator/Lecturer of Gynecology and obstetrics Faculty of medicine Beni-Suef University

Study Record Dates

• First Submitted: May 4, 2024
• First Posted: May 8, 2024
• Study Start: June 30, 2024
• Primary Completion: December 30, 2024
• Study Completion: December 30, 2024
• Last Updated: May 8, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)