NCT05091203

Brief Summary

Studying the effect of Vitamin D administration on assisted reproductive outcomes in women undergoing Intra Cytoplasmic Sperm Injection (ICSI) by giving a dose of vitamin D and determining the effect of this dose on both the quality embryos, implantation and ongoing pregnancy rate.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2022

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

October 2, 2021

Completed
23 days until next milestone

First Posted

Study publicly available on registry

October 25, 2021

Completed
1 year until next milestone

Study Start

First participant enrolled

November 1, 2022

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2023

Completed
Last Updated

January 29, 2024

Status Verified

January 1, 2024

Enrollment Period

12 months

First QC Date

October 2, 2021

Last Update Submit

January 26, 2024

Conditions

Role of Vitamin D in IVF for Better Outcome

Keywords

ICSI- Vitamin D- BMP-15 protein

Outcome Measures

Primary Outcomes (2)

  • Determine the level of Vitamin D in serum and follicular fluid in ng/ml

    Determine the level of Vitamin D in serum and follicular fluid in stimulated cycle for IVF/ICSI in normal responder women and comparison its level between study group (in which Vitamin D was administered) and control group ( in which vitamin D was not administrated) and its effect on oocyte quality by the use of ELISA test

    Stimulated Cycle a bout one month

  • Determine the level of BMP-15 in follicular fluid

    2- Determine the level of BMP-15 in follicular fluid in stimulated cycle for IVF/ICSI in normal responder women and comparison its level between study group(in which Vitamin D was administered) and control group ( in which vitamin D was not administrated) and its effect on oocyte quality by Western Plot test

    Stimulated Cycle within one month

Secondary Outcomes (2)

  • To find if there is a correlation between serum and follicular fluid level of Vitamin D in the same patient.

    Stimulated Cycle within one month

  • 4- To find if there is a relation between vitamin D and BMP 15 levels and other hormones like AMH, FSH, E2, TSH and prolactin

    Stimulated Cycle within one month

Study Arms (2)

control

SHAM COMPARATOR

Control group in which vitamin D was not administrated.

Drug: Vitamin D

Study group

ACTIVE COMPARATOR

Study group in which Vitamin D was administered

Drug: Vitamin D

Interventions

Vitamin DDRUG

To investigate role of vitamin D in follicular maturation and number of mature follicles which help in the success of IVF procedure

Study groupcontrol

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age is between 20-40 years old.
  • Non PCOS patient.
  • With no previous or current evidence of OHSS (number of oocyte between 5-15 oocytes)
  • Normal Prolactin level.
  • No other endocrinological abnormality including thyroid disorder or diabetes.
  • Within normal ovarian reserve AMH(1-3) ng/ml No evidence of endometriosis.
  • No other medical or surgical diseases.
  • Careful history, general and local examination, abdominal and vaginal ultrasonography and basal haematological and chemical investigations were done
  • to exclude any other abnormalities which can interfere with the result of the current study.

You may not qualify if:

  • Women older than 35 years of age or younger than 20 years old
  • Women with polycystic ovary syndrome PCOS (as defined according to the Rotterdam criteria)
  • Women who were diagnosed to have endometriosis within the last 1 year.
  • Women with ovarian hyper stimulation syndrome (OHSS).
  • Sever male factor infertility with immotile sperm which may affect embryo development
  • poor responder patient .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut university

Asyut, 71515, Egypt

Location

MeSH Terms

Interventions

Vitamin D

Intervention Hierarchy (Ancestors)

SecosteroidsSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle investigator

Study Record Dates

First Submitted

October 2, 2021

First Posted

October 25, 2021

Study Start

November 1, 2022

Primary Completion

October 31, 2023

Study Completion

November 30, 2023

Last Updated

January 29, 2024

Record last verified: 2024-01

Locations

EG(1)