Effects of Vitamin D Status on the Outcome of Ivf - Embryo Transfer

NCT ID: NCT03503006

Last Updated: 2020-03-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2569 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-03-21

Study Completion Date

2020-01-30

Brief Summary

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At present, there is no agreement on the effect of vitamin D level in serum and follicular fluid on the outcome of IVF-ET pregnancy. Most of these studies were based on the research of total 25 (OH) D, which have ignored that the biological activity of vitamin D molecule is not total 25 (OH) D, but free vitamin D or vitamin D bioavailable, and have flaws in methodology. This project intends to make a prospective cohort study with large sample, based on a complete methodology of total vitamin D and free vitamin D to measure maternal vitamin D levels in blood,to systematically study the effect of maternal vitamin D status on IVF - ET pregnancy outcome. This study is also the first to study the relationship between maternal vitamin D status and the outcome of IVF-ET pregnancy using a complete methodology.

Detailed Description

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Conditions

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Infertility, Female

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* female with only fallopian tube factor or male factor infertility,first IVF/ICSI cycle,18 years old≤age≤35 years old,take a long protocol or super-long protocol,18≤BMI≤25, menstrual regularity(periodic change \< 7 days)

Exclusion Criteria

* Hyperprolactinemia, Thyroid dysfunction, uterine malformation ( inadequacy mediastinal uterus ≥1.0cm, Unicornate uterus, double uterus, T Angle of uterus, etc.), uterus adhesion, untreated hydrosalpinx , hysteromyoma( hysteromyoma≥2.0 cm, and/or Uterine fibroids located within the endometrium≤1cm), endometriosis, diabetes, hypertension, adrenal cortex hyperplasia, Cushing's syndrome, a pituitary amenorrhea
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Reproductive & Genetic Hospital of CITIC-Xiangya

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Reproductive & Genetic Hospital of CITIC-XIANGYA

Changsha, Hunan, China

Site Status

Countries

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China

References

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Liu Y, Hocher JG, Ma S, Hu L, Chen H, Zhang X, Gong F, Kramer BK, Lin G, Hocher B. Pre-pregnancy LDL/HDL and total Cholesterol/HDL ratios are strong predictors of gestational diabetes mellitus in women undergoing assisted reproductive technologies. Reprod Biol Endocrinol. 2024 Dec 5;22(1):155. doi: 10.1186/s12958-024-01320-9.

Reference Type DERIVED
PMID: 39639281 (View on PubMed)

Other Identifiers

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LCYJ-201802

Identifier Type: -

Identifier Source: org_study_id

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