Skip to content

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

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06405204
Enrollment
200
Registered
2024-05-08
Start date
2024-06-30
Completion date
2024-12-30
Last updated
2024-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

IVF

Keywords

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

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

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

Interventions

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

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

DRUGMelatonin

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

DRUGFolic acid

control

Sponsors

Beni-Suef University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 40 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
pregnancy1 month of induction for ICSI trialserum HCG positive

Countries

Egypt

Contacts

Primary ContactSara S Sara Salem, MD
sara_abdallah100@yahoo.com+201272842226

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026