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Clinical trial

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

ID
Name
Co-enzyme q10
Description
To evaluate the role of Myo-inositol, melatonin and co-enzyme Q10 on ovarian reserve parameters and ICSI outcome in poor ovarian responder
Trial arms
Trial start
2024-06-30
Estimated PCD
2024-12-30
Trial end
2024-12-30
Status
Not yet recruiting
Phase
Early phase I
Treatment
Myoinositol
an enzymatic isoform of inositol and belongs to the vitamin B complex family
Arms:
myo-inositol
Other names:
femtonex, Viocyst
Co-Enzyme Q10
a lipid-soluble quinone, acting as an effective antioxidant,
Arms:
co-enzyme Q10
Other names:
Co Q
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
Arms:
melatonin
Folic acid
control
Arms:
control group.
Other names:
folicap
Size
200
Primary endpoint
pregnancy
1 month of induction for ICSI trial
Eligibility criteria
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 200, 'type': 'ESTIMATED'}}
Updated at
2024-05-08

1 organization

4 products

1 indication

Organization
Beni-Suef University
Product
Myoinositol
Indication
In vitro fertilization (IVF)
Product
Co-Enzyme Q10
Product
Melatonin
Product
Folic acid