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临床试验/NCT06721273
NCT06721273尚未招募不适用

The Effect of Iodine Supplementation on Fertility Parameters in Women Experiencing Infertility

Tehran University of Medical Sciences0 个研究点目标入组 230 人开始时间: 2025年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
230
主要终点
Number of retrieved oocytes

研究概览

简要总结

Iodine has been identified as a potential factor influencing female fertility during the childbearing years. The American Thyroid Association recommends that women attempting to conceive take a supplement containing 150 µg of iodine. However, no clinical trials have specifically examined the necessity of iodine supplementation in women experiencing infertility. Furthermore, no information is available on the optimal dose and duration of iodine supplementation to increase the chances of successful treatment in this group of women. Therefore, this study aims to investigate the effects of iodine supplementation on fertility parameters in infertile women.

详细描述

This double-blind randomized clinical trial will be conducted in infertility clinic on women with diminished ovarian reserve and undergoing in vitro fertilization (IVF) cycle treatment. According to the Bologna criteria, decreased ovarian reserve is defined as having 3 to 5 antral follicles and an anti-Müllerian hormone concentration ranging from 0.1 to 1.5 ng/ml. All women diagnosed with diminished ovarian reserve who meet the inclusion and exclusion criteria outlined in the general information section of the clinical trial and have provided written consent to participate will be examined. Following enrollment and baseline measurements, women will be randomly assigned to treatment groups-placebo and iodine supplement (150 µg/day of iodine)-in a 1:1 allocation ratio, using a random number table. In the intervention group, women will take 150 µg of iodine daily (one tablet per day, Tavan Institute, Tehran, Iran) for two months prior to starting the new IVF cycle. In the control group, participants will take a placebo tablet daily (containing white wheat flour, designed to match the size, shape, and color of the iodine tablet, Tavan Institute, Tehran, Iran) for the same duration before beginning the new IVF cycle. Women of two groups will be followed until the end of IVF cycle. Women in both groups will be monitored until the completion of the IVF cycle. Throughout the study, the following parameters will be assessed based on the timeline of the IVF cycle: the number of retrieved oocytes, the number of mature (MII) oocytes, the number of embryos, embryo quality, biochemical pregnancy, and clinical pregnancy.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Women with diminished ovarian reserve
  • Willingness to participate
  • Age range: 18 to 45 years
  • Women with a menstrual cycle of 21 to 42 days
  • Women who have not used any contraceptive methods in the past 12 months
  • Women who have not had in sexual intercourse for more than 2 months

排除标准

  • Unwillingness to participate
  • Women with polycystic ovary syndrome or endometriosis
  • Diagnosis of any thyroid disease
  • Use of any medication that affects the thyroid function
  • Use of dietary supplements containing iodine (excluding those considered in the present study)
  • Use of iodine-containing disinfectants

结局指标

主要结局

Number of retrieved oocytes

时间窗: 2 weeks after the start of ovarian stimulation (approximately 2 months after intervention)

Total count of mature eggs (oocytes) collected from a woman's ovaries during an IVF cycle through the egg retrieval procedure by embryologists

Number of mature (MII) oocytes

时间窗: 2 weeks after the start of ovarian stimulation (approximately 2 months after intervention)

Total count of oocytes that have reached the metaphase II stage of meiosis. This measurement is done by embryologists

次要结局

  • Number of embryos(16-18 hours after insemination)
  • Quality of embryos(3 days after fertilization)
  • Biochemical pregnancy(12 days after embryo transfer)
  • Clinical pregnancy(3 weeks after embryo transfer)

研究者

申办方类型
Other
责任方
Sponsor

相似试验

Iodine Supplementation and Fertility Parameters | 临床试验