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An Investigation of the Effect of Vitamin D Level During Frozen Embryo Transfer (FET) in IVF and Pregnancy Outcomes (VitD in FET)

13. juli 2026 oppdatert av: Fakih IVF Fertility Center

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.

Studieoversikt

Detaljert beskrivelse

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

Observasjonsmessig

Registrering (Antatt)

126

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen

Tar imot friske frivillige

Nei

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

Women undergoing FET cycle who do not suffer from conditions affecting implantation and have got vitamin D levels tested 3 - 6 months before FET cycle.

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / Behandling
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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
Clinical pregnancy test
Tidsramme: 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
Tidsramme: Vitamin D level tested on the day of FET.
Vitamin D level tested on the day of FET.

Sekundære resultatmål

Resultatmål
Tidsramme
Live birth rate, miscarriage rate, and preterm birth rate.
Tidsramme: From enrollment to six weeks post partum
From enrollment to six weeks post partum

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

  • Hovedetterforsker: Michael Fakih, MD, Fakih IVF Abu Dhabi
  • Hovedetterforsker: Lamiya Mohiyiddeen, MD, FRCOG, Fakih IVF Abu Dhabi

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. juni 2026

Primær fullføring (Antatt)

1. juni 2027

Studiet fullført (Antatt)

1. august 2027

Datoer for studieregistrering

Først innsendt

26. juni 2026

Først innsendt som oppfylte QC-kriteriene

26. juni 2026

Først lagt ut (Faktiske)

2. juli 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

15. juli 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

13. juli 2026

Sist bekreftet

1. juli 2026

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • FAKIHIVF-2025-5
  • DOH/ADHRTC/2025/1884 (Annen identifikator: Department of Health Abu Dhabi)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

Not an NIH project

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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