Effect of Vitamin D on Vaginal / Endometrial Biomarkers and Endometrial Receptivity in Women With Fertility Problems
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- Change in endometrial receptivity
研究概览
简要总结
This is a prospective study comparing vaginal and endometrial biomarkers and the trophoblast spheroid attachment rate in women with fertility problems before and after taking Vitamin D for 8 weeks.
详细描述
The aim of this study is to assess the effect of vitamin D supplementation on vaginal / endometrial biomarkers and endometrial receptivity in women with fertility problems.
Women will have vaginal swab and endometrial biopsy twice. The first endometrial biopsy is performed using a Pipelle sampler 7 days after luteinizing hormone surge (LH+7) at baseline and the attachment rate of the trophoblast spheroid onto the isolated endometrial epithelial cells will be assessed to assess endometrial receptivity at baseline. Implantation biomarkers will be checked.
They will take Vitamin D 50,000 IU once per week for 4 weeks, followed by 50,000 IU once every 2 weeks for 4 weeks. After 8 weeks of Vitamin D, a second vaginal swab and endometrial biopsy using a Pipelle sampler by standard technique will be collected from the patients 7 days after luteinizing hormone surge (LH+7) and the endometrial receptivity will be compared.
The laboratory staff will not know whether the patient is taking any vitamin D when performing the trophoblast spheroid attachment assay/ biomarkers.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age of women < 40years old
- •Normal uterine cavity as demonstrated by pelvic scanning with or without saline infusion sonogram or hysteroscopy
- •Regular ovulatory cycles
- •They will be divided into three groups:
- •RIF patients (n=35)- those who have failed to get pregnant after replacing four or more cleavage stage embryos or two or more blastocysts in two consecutive transfers.
- •RPL patients (n=35)- those who have failed in three pregnancies before 24 weeks of gestation and includes embryonic and fetal losses.
- •'Infertile group'(n=35)- infertility except RIF and RPL, e.g. those seeking for preimplantation genetic testing, male factor infertility, unexplained infertility.
排除标准
- •History of any medical condition or medications that may predispose to vitamin D sensitivity, altered vitamin D metabolism and/ or hypercalcemia, including active tuberculosis or current therapy for tuberculosis, sarcoidosis, history of renal/ ureteral stones, parathyroid disease, renal or liver failure or current use of anti-convulsants
- •Taking vitamin D supplement
- •Endometrial polyp or fibroid distorting the uterine cavity
- •Presence of hydrosalpinx not corrected surgically
- •Refusal to join the study
- •Discontinuation criteria-
- •If the woman becomes pregnant during the study
- •Pelvic inflammatory disease/ uterine perforation after endometrial biopsy
- •Vitamin D toxicity (hypercalcemia)
- •Withdrawal by patient
结局指标
主要结局
Change in endometrial receptivity
时间窗: 8 weeks
Assessed by the attachment rate of trophoblast spheroid attachment assay onto the isolated endometrial epithelial cells
次要结局
未报告次要终点