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临床试验/NCT06405204
NCT06405204尚未招募3 期

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

Beni-Suef University1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2024年6月30日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
尚未招募
入组人数
200
试验地点
1
主要终点
pregnancy

研究概览

简要总结

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

详细描述

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

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
20 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

  • Any endocrine or metabolic disorder such as hyperprolactinemia, diabetes and thyroid dysfunction
  • Any pelvic pathology such as hydrosalpinx, uterine anomaly.
  • Any male factor infertility such as Oligo-Astheno-Teratozoospermia (OAT) or azoospermia

研究组 & 干预措施

myo-inositol

Experimental

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

干预措施: Myoinositol (Drug)

melatonin

Experimental

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

干预措施: Melatonin (Drug)

co-enzyme Q10

Experimental

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

干预措施: Co-Enzyme Q10 (Drug)

control group.

Placebo Comparator

will receive folic acid 400 mcg per day

干预措施: Folic acid (Drug)

结局指标

主要结局

pregnancy

时间窗: 1 month of induction for ICSI trial

serum HCG positive

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sara Abdallah Mohamed Salem

principle investigator/Lecturer of Gynecology and obstetrics Faculty of medicine Beni-Suef University

Beni-Suef University

研究点 (1)

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