Follicular Fluid Fetuins in in Vitro Fertilization

Follicular Fetuin A and Fetin B Levels Are Associated With Clinical Pregnancy and Live Birth Rates in IVF Cycles

This study aims to investigate whether follicular fluid concentrations of fetuin A and fetuin B are associated with the clinical pregnancy and live birth rates in in vitro fertilization (IVF) cycles.Twenty-nine women with poor ovarian reserve (poor responders) and 33 women with polycystic ovary syndrome (hyper responders) who consecutively underwent IVF at a private hospital between May 2018 and February 2019.Fetuin A and fetuin B in follicular fluid were significantly lower in women who had clinical pregnancy than women who had no clinical pregnancy (p=0.001 for both)

Study Overview

• Status: Completed
• Conditions: Infertility; Infertility, Female
• Intervention / Treatment: Diagnostic test: Serum test

• Study Type: Interventional
• Enrollment (Actual): 96
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Samsun, Turkey, 55000
    • Samettin Çelik

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

Poor ovarian reserve patients and patient with polycystic ovary syndrome

Exclusion Criteria:

Normoresponders

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Infertile women with normal ovarian reserve; Infertile women with normal ovarian reserve will be included.	Diagnostic test: Serum test; Serum Fetuin A and fetuin B; Other Names: FOLLICULAR FETUIN B LEVELS IN IVF
ACTIVE_COMPARATOR: Infertile women with high ovarian reserve; Infertile women with high ovarian reserve will be included.	Diagnostic test: Serum test; Serum Fetuin A and fetuin B; Other Names: FOLLICULAR FETUIN B LEVELS IN IVF
ACTIVE_COMPARATOR: Infertile women with poor ovarian reserve; Infertile women with poor ovarian reserve will be included.	Diagnostic test: Serum test; Serum Fetuin A and fetuin B; Other Names: FOLLICULAR FETUIN B LEVELS IN IVF

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
he primary outcome of this study is to measure the follicüler fluid concentrations of fetuin A and fetuin B in IVF cycles. Follicular fluid Fetuin A and Fetuin B will be measured during oosit pick up in IVF cycles.	The relationship between fetuin A and insulin resistance suggests the probable role of this glycoprotein in human fertility. Fetuin B prevents the hardening of zona pellucida by inhibiting ovastacin.In this study, follicular fluid concentrations of fetuin A and fetuin B are measured in IVF cycles	4 weeks
The secondary goal of this study is to whether follicular fluid concentrations of fetuin A and fetuin B are associated with clinical pregnancy and live birth rates in IVF cycles.	The oocyte fluid samples that are derived from the largest follicles and contained oocytes are collected for the measurement of fetuin A and fetuin B concentrations. Follicular fluid samples are centrifuged at 3000 g for 10 minutes and stored at -80ºC up to the working day. On the working day, samples are brought to room temperature. The fertilized embryos are transferred into the uterine cavity on the 2nd day.A pregnancy test is performed on the 12th day following embryo transfer, hCG-positive patients undergot transvaginal ultrasound scan on 21st day for detection of clinical pregnancy.	8 weeks

Collaborators and Investigators

• Sponsor: Samsun Education and Research Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 20, 2018
• Primary Completion (ACTUAL): February 25, 2019
• Study Completion (ACTUAL): October 20, 2019

Study Registration Dates

• First Submitted: December 13, 2019
• First Submitted That Met QC Criteria: December 14, 2019
• First Posted (ACTUAL): December 17, 2019

Study Record Updates

• Last Update Posted (ACTUAL): November 6, 2020
• Last Update Submitted That Met QC Criteria: November 4, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infertility; Infertility, Female
• Other Study ID Numbers: KAEK-2019/4/27

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No