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

IVF Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06405204
• Other study ID #: Co-enzyme q10
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: June 30, 2024
• Est. completion date: December 30, 2024

Study information

• Verified date: May 2024
• Source: Beni-Suef University
• Contact: Sara S Sara Salem, MD
• Phone: +201272842226
• Email: sara_abdallah100[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: December 30, 2024
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• IVF

Intervention

Drug:
• Myoinositol
an enzymatic isoform of inositol and belongs to the vitamin B complex family
• Co-Enzyme Q10
a lipid-soluble quinone, acting as an effective antioxidant,
• 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
• Folic acid
control

Locations

Country	Name	City	State
Egypt	Beni-suef university Hospital	Bani Suwayf

Sponsors (1)

Lead Sponsor	Collaborator
Beni-Suef University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pregnancy	serum HCG positive	1 month of induction for ICSI trial