NCT02987478

Brief Summary

All patients will undergo in vitro fertilization. Serum 25 (OH) D samples will be collected within1 week before oocyte retrieval. Whole blood specimens will be collected in serum separator tubes using acceptable medical techniques to avoid hemolysis. Ultrasound guided fresh embryo transfer will be performed on day 5 after fertilization. clinical pregnancy will be confirmed by observation of intrauterine sac visible on ultrasound performed 4-5 weeks after embryo transfer.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
240

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2016

Geographic Reach
1 country

1 active site

Status
unknown

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

March 1, 2016

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

November 29, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 9, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

December 9, 2016

Status Verified

December 1, 2016

Enrollment Period

1 year

First QC Date

November 29, 2016

Last Update Submit

December 6, 2016

Conditions

Keywords

Vitamin D following intra cytoplasmic sperm injection

Outcome Measures

Primary Outcomes (1)

  • pregnancy

    4-5 weeks

Eligibility Criteria

Age20 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

* Age between 20 and 35 years old. * Body mass index between 20 - 30. * Unexplained infertility . * Follicle-stimulating hormone level 12 IU/L or lower (baseline level, cycle day 3). * Normal hysteroscopy . * Fresh embryo transfer of 2 or more blastocysts stage. * Embryo transfer on day 5 after fertilization

You may qualify if:

  • Age between 20 and 35 years old.
  • Body mass index between 20 - 30.
  • Unexplained infertility .
  • Follicle-stimulating hormone level 12 IU/L or lower (baseline level, cycle day 3).
  • Normal hysteroscopy ( healthy uterus with no fibroids or other growths)
  • Fresh embryo transfer of 2 or more blastocysts stage.
  • Embryo transfer on day 5 after fertilization

You may not qualify if:

  • Women younger than 20 years old or older than 35 years old.
  • Previous one or more failed IVF.
  • Uncorrected congenital or acquired uterine anomalies.
  • Other causes of infertility rather than unexplained infertility.
  • Less than 2 embryo transfer, cleavage stager frozen embryo transfer.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams University Maternity Hospital

Cairo, Abbassia, 11566, Egypt

RECRUITING

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

November 29, 2016

First Posted

December 9, 2016

Study Start

March 1, 2016

Primary Completion

March 1, 2017

Study Completion

December 1, 2017

Last Updated

December 9, 2016

Record last verified: 2016-12

Locations