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

Beni-Suef University

Status and phase: Not yet enrolling; Phase 3

Conditions: IVF

Treatments: Drug: Myoinositol; Drug: Melatonin; Drug: Co-Enzyme Q10; Drug: Folic acid

Study type: Interventional

Funder types: Other

Identifiers

NCT06405204

Co-enzyme q10

Details and patient eligibility

About

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

Full 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

Enrollment: 200 estimated patients

Sex: Female

Ages: 20 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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200 participants in 4 patient groups, including a placebo group

myo-inositol

Experimental group

Description:

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

Treatment:

Drug: Myoinositol

melatonin

Experimental group

Description:

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

Treatment:

Drug: Melatonin

co-enzyme Q10

Experimental group

Description:

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

Treatment:

Drug: Co-Enzyme Q10

control group.

Placebo Comparator group

Description:

will receive folic acid 400 mcg per day

Treatment:

Drug: Folic acid