Back to resultsFollicular Fluid Fetuins in in Vitro Fertilization
Primary Purpose
Infertility, Infertility, Female
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Serum test
Sponsored by
About this trial
This is an interventional basic science trial for Infertility
Eligibility Criteria
Inclusion Criteria:
Poor ovarian reserve patients and patient with polycystic ovary syndrome
Exclusion Criteria:
Normoresponders
Sites / Locations
- Samettin Çelik
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Infertile women with normal ovarian reserve
Infertile women with high ovarian reserve
Infertile women with poor ovarian reserve
Arm Description
Infertile women with normal ovarian reserve will be included.
Infertile women with high ovarian reserve will be included.
Infertile women with poor ovarian reserve will be included.
Outcomes
Primary Outcome Measures
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
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04201847
First Posted
December 13, 2019
Last Updated
November 4, 2020
Sponsor
Samsun Education and Research Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04201847
Brief Title
Follicular Fluid Fetuins in in Vitro Fertilization
Official Title
Follicular Fetuin A and Fetin B Levels Are Associated With Clinical Pregnancy and Live Birth Rates in IVF Cycles
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
May 20, 2018 (Actual)
Primary Completion Date
February 25, 2019 (Actual)
Study Completion Date
October 20, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samsun Education and Research Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility, Infertility, Female
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
96 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Infertile women with normal ovarian reserve
Arm Type
Active Comparator
Arm Description
Infertile women with normal ovarian reserve will be included.
Arm Title
Infertile women with high ovarian reserve
Arm Type
Active Comparator
Arm Description
Infertile women with high ovarian reserve will be included.
Arm Title
Infertile women with poor ovarian reserve
Arm Type
Active Comparator
Arm Description
Infertile women with poor ovarian reserve will be included.
Intervention Type
Diagnostic Test
Intervention Name(s)
Serum test
Other Intervention Name(s)
FOLLICULAR FETUIN B LEVELS IN IVF
Intervention Description
Serum Fetuin A and fetuin B
Primary Outcome Measure Information:
Title
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.
Description
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
Time Frame
4 weeks
Title
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.
Description
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.
Time Frame
8 weeks
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Poor ovarian reserve patients and patient with polycystic ovary syndrome
Exclusion Criteria:
Normoresponders
Facility Information:
Facility Name
Samettin Çelik
City
Samsun
ZIP/Postal Code
55000
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
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Follicular Fluid Fetuins in in Vitro Fertilization
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