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.
Studie Overzicht
Toestand
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Geschat)
Contacten en locaties
Studiecontact
- Naam: Dr. Lamiya Mohiyiddeen, MD, FRCOG
- Telefoonnummer: +971543676002
- E-mail: lamiya.mohiyiddeen@fakihivf.com
Studie Contact Back-up
- Naam: Fatma Bathawab, PhD
- Telefoonnummer: +971585707393
- E-mail: fatma.bathawab@fakihivf.com
Studie Locaties
-
-
-
Abu Dhabi, Verenigde Arabische Emiraten
- Werving
- Fakih IVF Fertility Centre LLC
-
Contact:
- Dr. Lamiya Mohiyiddeen, MD, FRCOG
- Telefoonnummer: +971543676002
- E-mail: lamiya.mohiyiddeen@fakihivf.com
-
Contact:
- Fatma Bathawab, PhD
- Telefoonnummer: +971585707393
- E-mail: fatma.bathawab@fakihivf.com
-
Hoofdonderzoeker:
- Michael Fakih, MD
-
Hoofdonderzoeker:
- Lamiya Mohiyiddeen, MD, FRCOG
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
Accepteert gezonde vrijwilligers
Bemonsteringsmethode
Studie Bevolking
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
|---|---|
|
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.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
|
Clinical pregnancy test
Tijdsspanne: 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
Tijdsspanne: Vitamin D level tested on the day of FET.
|
Vitamin D level tested on the day of FET.
|
Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
|
Live birth rate, miscarriage rate, and preterm birth rate.
Tijdsspanne: From enrollment to six weeks post partum
|
From enrollment to six weeks post partum
|
Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Michael Fakih, MD, Fakih IVF Abu Dhabi
- Hoofdonderzoeker: Lamiya Mohiyiddeen, MD, FRCOG, Fakih IVF Abu Dhabi
Publicaties en nuttige links
Algemene publicaties
- 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.
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Andere studie-ID-nummers
- FAKIHIVF-2025-5
- DOH/ADHRTC/2025/1884 (Andere identificatie: Department of Health Abu Dhabi)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .