NCT05137964

Brief Summary

Evaluation of the association between vitamin D (VD) deficiency and ovarian reserve markers in a group of Pakistani sub fertile women was conducted

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
199

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2016

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2016

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2021

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 5, 2021

Completed
25 days until next milestone

First Posted

Study publicly available on registry

November 30, 2021

Completed
Last Updated

November 30, 2021

Status Verified

November 1, 2021

Enrollment Period

4.9 years

First QC Date

November 5, 2021

Last Update Submit

November 16, 2021

Conditions

Subfertility, Female

Keywords

subfertilefemale

Outcome Measures

Primary Outcomes (1)

  • Correlation

    To address gaps in local data, this study was conducted to explore the association between VDD and ovarian reserve, via measurements of AFC, AMH, FSH and 25-hydroxy vitamin D (25-OHD) in Pakistani women.

    Aug 2016 to July 2021

Study Arms (2)

Vitamin D Deficient

deficiency (\<20ng/ml)

Diagnostic Test: Vitamin D

Vitamin D Sufficient

sufficiency (\>30ng/ml)

Diagnostic Test: Vitamin D

Interventions

Vitamin DDIAGNOSTIC_TEST

Serum Biochemical routine lab workup and gynaecological ultra sound AFC

Also known as: Serum AMH, 25-hydroxyvitamin D (25-OHD), FSH and Antral Follicle Count (AFC) via ultra sound
Vitamin D DeficientVitamin D Sufficient

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Pakistani female patients aged 18 to 45 years, presenting with primary and/or secondary subfertility

You may qualify if:

  • Clinical diagnosis of primary and/or secondary subfertility

You may not qualify if:

  • Patients with missing data i.e., BMI, duration of subfertility, age, AMH, 25-hydroxyvitamin D (25-OHD), AFC and FSH.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Infertility, Female

Interventions

Vitamin D Response Element

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesInfertility

Intervention Hierarchy (Ancestors)

Response ElementsEnhancer Elements, GeneticRegulatory Sequences, Nucleic AcidBase SequenceMolecular StructureBiochemical PhenomenaChemical PhenomenaPromoter Regions, GeneticGenetic StructuresGenetic PhenomenaRegulatory Elements, TranscriptionalGene ComponentsGenesGenome ComponentsGenome

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant Gyn Obs

Study Record Dates

First Submitted

November 5, 2021

First Posted

November 30, 2021

Study Start

August 1, 2016

Primary Completion

July 1, 2021

Study Completion

July 1, 2021

Last Updated

November 30, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share