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临床试验/NCT07681115
NCT07681115招募中不适用

Vitamin D Levels and Pregnancy Outcomes Following Frozen Embryo Transfer (FET) in the UAE

Fakih IVF Fertility Center1 个研究点 分布在 1 个国家目标入组 126 人开始时间: 2026年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
126
试验地点
1
主要终点
Clinical pregnancy test

研究概览

简要总结

Vitamin D is best known for keeping our bones healthy, but growing research suggests it may also play a role in fertility. Many In vitro fertilization (IVF) clinics now routinely check vitamin D levels and prescribe supplements before treatment, but the science is still unclear on whether this actually improves the chances of pregnancy.

Our study, based in the United Arab Emirates (UAE), aims to find out whether a woman's vitamin D level on the day of her frozen embryo transfer (FET) makes a difference to whether she becomes pregnant and delivers a baby. The UAE is an ideal setting for this research, as vitamin D deficiency is particularly common in the region. The findings could shape how fertility clinics screen and treat women seeking fertility treatment in the future.

详细描述

Serum vitamin D3 has attracted growing research interest for its potential role in female reproductive physiology. While some studies associate sufficient vitamin D3 levels with improved IVF outcomes, others have failed to confirm this, leaving the evidence base contested. Despite this uncertainty, pre-In vitro fertilization (IVF) vitamin D screening and supplementation of insufficient patients has become widespread clinical practice. Evidence specific to frozen embryo transfer (FET) cycles remains particularly limited. Recent prospective studies found no significant difference in ongoing pregnancy, live birth, or implantation rates between vitamin D3-insufficient women receiving supplementation and vitamin D3-replete women who did not, underscoring the need for higher-quality, targeted research. While emerging data support a role for vitamin D in endometrial receptivity, it remains unclear whether correcting insufficiency prior to FET meaningfully improves reproductive success.

To address these gaps, our study will evaluate the association between serum vitamin D3 levels on the day of FET and subsequent pregnancy and delivery outcomes at a UAE fertility center. Supplementation history and relevant clinical variables will be captured via patient questionnaire. Vitamin D status will be classified per International Society of Endocrinology guidance: deficient (<20 ng/mL), insufficient (20-29 ng/mL), and sufficient (≥30 ng/mL). Given the high regional prevalence of vitamin D deficiency, this study is well-positioned to determine whether vitamin D status represents a modifiable determinant of reproductive success, with direct implications for clinical screening and management protocols in this population.

研究设计

研究类型
Observational
观察模型
Cohort
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

入选标准

  • Women undergoing frozen embryo transfer (FET) at Fakih IVF.
  • Age between 18 and 40 years.
  • Body mass index (BMI) between 18 and 40 kg/m².
  • Patients who had serum vitamin D levels assessed within three months prior to FET
  • Supplementation with Vitamin D if deficient < 30 ng/mL (75 nmol/L).

排除标准

  • Age below 18 years or above 40 years.
  • BMI below 18 kg/m² or above 40 kg/m².
  • Patients who did not have vitamin D levels measured within three months prior to FET.
  • Patients who were found to have low vitamin D levels but did not receive supplementation.
  • Patients with recurrent implantation failure (RIF).
  • Patients with known uterine factors affecting implantation (e.g., congenital uterine anomalies, intrauterine adhesions, submucosal fibroids).
  • Patients with significant medical comorbidities that may affect pregnancy outcomes.

研究组 & 干预措施

Women undergoing frozen embryo transfer (FET) at Fakih IVF

The study will enroll women aged 18-40 years with a BMI of 18-40 kg/m² undergoing FET at Fakih IVF, who had serum vitamin D assessed within three months prior to transfer. Women with deficient levels (<30 ng/mL) must have received supplementation prior to FET to be eligible.

Exclusions are designed to reduce confounding: women are excluded if vitamin D was not measured within the required window, if identified deficiency went untreated, or if they have a history of recurrent implantation failure (RIF). Women with uterine factors known to impair implantation including congenital anomalies, intrauterine adhesions, or submucosal fibroids are also excluded, as are those with significant medical comorbidities that may independently affect pregnancy outcomes.

干预措施: No Intervention: Observational Cohort (Other)

结局指标

主要结局

Clinical pregnancy test

时间窗: From enrollment on day of FET to 1 month post FET

Serum 25(OH)D levels measured on the day of FET.

时间窗: Vitamin D level tested on the day of FET cyle.

Concentration of serum 25-hydroxyvitamin D levels measured on the day of FET

时间窗: Vitamin D level tested on the day of FET.

次要结局

  • Live birth rate, miscarriage rate, and preterm birth rate.(From enrollment to six weeks post partum)

研究者

发起方
Fakih IVF Fertility Center
申办方类型
Other
责任方
Sponsor

研究点 (1)

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