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

Phase 3

Not yet recruiting

• Conditions: IVF
• Interventions: Drug: Co-Enzyme Q10; Drug: Myoinositol; Drug: Melatonin; Drug: Folic acid

• Registration Number: NCT06405204
• Lead Sponsor: Beni-Suef University

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

Study Timeline

• Status Verified: 2024-05
• Study First Submitted: 2024-05-04
• Study First Submitted QC: 2024-05-04
• Last Update Submitted: 2024-05-04
• Study First Posted: 2024-05-08
• Last Update Posted: 2024-05-08
• Study Start: 2024-06-30
• Primary Completion: 2024-12-30
• Study Completion: 2024-12-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 200

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
co-enzyme Q10	Co-Enzyme Q10	co-enzyme Q10 100mg per day plus folic acid 400 mcg per day
myo-inositol	Myoinositol	myo-inositol (1gm capsules bd ) plus folic acid 400 mcg per day
melatonin	Melatonin	melatonin 1 capsule every night orally before going to bed plus folic acid 400mcg per day
control group.	Folic acid	will receive folic acid 400 mcg per day

Primary Outcome Measures

Name	Time	Method
pregnancy	1 month of induction for ICSI trial	serum HCG positive

Trial Locations

Locations (1)

Beni-suef university Hospital; 🇪🇬 Banī Suwayf, Egypt