NCT04201847

Brief Summary

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)

Trial Health

87
On Track

Trial Health Score

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

Enrollment
96

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2018

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 20, 2018

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 25, 2019

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 20, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 13, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 17, 2019

Completed
Last Updated

November 6, 2020

Status Verified

November 1, 2020

Enrollment Period

9 months

First QC Date

December 13, 2019

Last Update Submit

November 4, 2020

Conditions

InfertilityInfertility, Female

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (3)

Infertile women with normal ovarian reserve

ACTIVE COMPARATOR

Infertile women with normal ovarian reserve will be included.

Diagnostic Test: Serum test

Infertile women with high ovarian reserve

ACTIVE COMPARATOR

Infertile women with high ovarian reserve will be included.

Diagnostic Test: Serum test

Infertile women with poor ovarian reserve

ACTIVE COMPARATOR

Infertile women with poor ovarian reserve will be included.

Diagnostic Test: Serum test

Interventions

Serum testDIAGNOSTIC_TEST

Serum Fetuin A and fetuin B

Also known as: FOLLICULAR FETUIN B LEVELS IN IVF
Infertile women with high ovarian reserveInfertile women with normal ovarian reserveInfertile women with poor ovarian reserve

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Poor ovarian reserve patients and patient with polycystic ovary syndrome

You may not qualify if:

  • Normoresponders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samettin Çelik

Samsun, 55000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

InfertilityInfertility, Female

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy Complications

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Director

Study Record Dates

First Submitted

December 13, 2019

First Posted

December 17, 2019

Study Start

May 20, 2018

Primary Completion

February 25, 2019

Study Completion

October 20, 2019

Last Updated

November 6, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)