An Investigation of the Effect of Vitamin D Level During Frozen Embryo Transfer (FET) in IVF and Pregnancy Outcomes (VitD in FET)
Vitamin D Levels and Pregnancy Outcomes Following Frozen Embryo Transfer (FET) in the UAE
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.
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前:Dr. Lamiya Mohiyiddeen, MD, FRCOG
- 電話番号:+971543676002
- メール:lamiya.mohiyiddeen@fakihivf.com
研究連絡先のバックアップ
- 名前:Fatma Bathawab, PhD
- 電話番号:+971585707393
- メール:fatma.bathawab@fakihivf.com
研究場所
-
-
-
Abu Dhabi、アラブ首長国連邦
- 募集
- Fakih IVF Fertility Centre LLC
-
コンタクト:
- Dr. Lamiya Mohiyiddeen, MD, FRCOG
- 電話番号:+971543676002
- メール:lamiya.mohiyiddeen@fakihivf.com
-
コンタクト:
- Fatma Bathawab, PhD
- 電話番号:+971585707393
- メール:fatma.bathawab@fakihivf.com
-
主任研究者:
- Michael Fakih, MD
-
主任研究者:
- Lamiya Mohiyiddeen, MD, FRCOG
-
-
参加基準
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
説明
Inclusion:
- 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).
Exclusion:
- 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.
研究計画
研究はどのように設計されていますか?
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
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. |
There are no interventions in this study.
This is an observational cohort study.
|
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
|
Clinical pregnancy test
時間枠:From enrollment on day of FET to 1 month post FET
|
From enrollment on day of FET to 1 month post FET
|
|
Concentration of serum 25-hydroxyvitamin D levels measured on the day of FET
時間枠:Vitamin D level tested on the day of FET.
|
Vitamin D level tested on the day of FET.
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
Live birth rate, miscarriage rate, and preterm birth rate.
時間枠:From enrollment to six weeks post partum
|
From enrollment to six weeks post partum
|
協力者と研究者
捜査官
- 主任研究者:Michael Fakih, MD、Fakih IVF Abu Dhabi
- 主任研究者:Lamiya Mohiyiddeen, MD, FRCOG、Fakih IVF Abu Dhabi
出版物と役立つリンク
一般刊行物
- Wang K, Dong F, Ma S, Bu Z. The association between Vitamin D deficiency and clinical pregnancy rate in IVF patients with different age. Front Endocrinol (Lausanne). 2025 Jan 3;15:1485238. doi: 10.3389/fendo.2024.1485238. eCollection 2024.
- Holick MF, Binkley NC, Bischoff-Ferrari HA, Gordon CM, Hanley DA, Heaney RP, Murad MH, Weaver CM; Endocrine Society. Evaluation, treatment, and prevention of vitamin D deficiency: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab. 2011 Jul;96(7):1911-30. doi: 10.1210/jc.2011-0385. Epub 2011 Jun 6.
- Chu J, Gallos I, Tobias A, Tan B, Eapen A, Coomarasamy A. Vitamin D and assisted reproductive treatment outcome: a systematic review and meta-analysis. Hum Reprod. 2018 Jan 1;33(1):65-80. doi: 10.1093/humrep/dex326.
- Anifandis, G., Dafopoulos, K., Messini, C. I., et al. (2021). The impact of vitamin D supplementation on reproductive outcomes in infertile women: A systematic review and meta-analysis. Hormones (Athens), 20(2), 145-154. https://doi.org/10.1007/s42000-021-00291-1
- Lerchbaum E, Obermayer-Pietsch B. Vitamin D and fertility: a systematic review. Eur J Endocrinol. 2012 May;166(5):765-78. doi: 10.1530/EJE-11-0984. Epub 2012 Jan 24.
- Hu KL, Gan K, Wang R, Li W, Wu Q, Zheng B, Zou L, Zhang S, Liu Y, Wu Y, Chen R, Cao W, Yang S, Liu FT, Tian L, Zeng H, Xu H, Qiu S, Yang L, Chen X, Pan X, Wu X, Mol BW, Li R, Zhang D. Vitamin D supplementation prior to in vitro fertilisation in women with polycystic ovary syndrome: a protocol of a multicentre randomised, double-blind, placebo-controlled clinical trial. BMJ Open. 2020 Dec 8;10(12):e041409. doi: 10.1136/bmjopen-2020-041409.
- Christoforidis N, Papapanou M, Michalakis D, Dimitraki M, Chatziparasidou A, Siristatidis C. Effect of vitamin D supplementation on frozen embryo transfer cycle outcomes. Hum Fertil (Camb). 2025 Dec;28(1):2493251. doi: 10.1080/14647273.2025.2493251. Epub 2025 Apr 25.
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- FAKIHIVF-2025-5
- DOH/ADHRTC/2025/1884 (その他の識別子:Department of Health Abu Dhabi)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。