Follicular Fluid Sialic Acid Levels in IVF Cycles

February 24, 2019 updated by: Berna Aslan Cetin, Kanuni Sultan Suleyman Training and Research Hospital

Follicular Fluid Sialic Acid Levels in in Vitro Fertilization Cycles

This cross-sectional study was conducted at the Reproductive Endocrinology and Invitro Fertilization (REI) unit of our hospital, following the approval of the hospital's ethics committee. Patients who underwent gonadotropin-releasing hormone agonist (GnRHa) treatment were enrolled in the study. During oocyte retrieval, follicular fluids of mature follicles (≥18 mm) were collected and pooled for each patient. The thiobarbituric acid method was used for the sialic acid levels and the absorbance values were measured by a spectrophotometer at 549 nm.

Study Overview

Status

Completed

Detailed Description

This cross-sectional study was conducted at the Reproductive Endocrinology and Invitro Fertilization (REI) unit our hospital, following the approval of the hospital's ethics committee. The inclusion criteria were as follows; under 40 years of age, normal thyroid and prolactin hormone levels, a basal follicle stimulating hormone (FSH) level <10 mIU/mL, BMI of 19-30 kg/m2. Exclusion criteria: a history of ovarian surgery, endometriosis, uterine anomaly, any endocrine disease including congenital adrenal hyperplasia, smokers, use of any medications and hormones in the last 3 months. Before the IVF treatment serum follicle stimulating hormone (FSH), luteinizing hormone (LH), prolactin (PRL), thyroid-stimulating hormone (TSH), and estradiol (E2) levels were measured on the third day of the cycle. Age, body mass index, duration of stimulation, duration of infertility, the total dose of gonadotropins, E2 on the day of hCG administration, number of oocytes retrieved, fertilization rate, and pregnancy rate were recorded.

All patients underwent gonadotropin-releasing hormone agonist (GnRHa) treatment. Oocyte retrieval was done 36 hours after the hCG injection and ICSI was used for all patients. Embryo transfer was performed 48-72 hours after the oocyte retrieval.

During oocyte retrieval, follicular fluids of mature follicles (≥18 mm) were collected from the first follicle entered and were aspirated for each patient. Follicle aspirates, which were not clear and contaminated with blood, were excluded. Total and free sialic acid levels were measured in the follicular fluid.

Study Type

Interventional

Enrollment (Actual)

87

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Istanbul, Turkey, 34303
        • Kanuni SSRTH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • under 40 years of age,
  • normal thyroid and prolactin hormone levels,
  • a basal follicle stimulating hormone (FSH) level <10 mIU/mL,
  • body mass index (BMI) of 19-30 kg/m2

Exclusion Criteria:

  • a history of ovarian surgery, endometriosis, uterine anomaly,
  • any endocrine disease including congenital adrenal hyperplasia,
  • smokers,
  • use of any medications and hormones in the last 3 months.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: In vitro fertilization
Paients undergoing in vitro fertilization with Gonadotropin-releasing Hormone agonist. Follicular fluid sialic acid levels will be measured.
All patients underwent gonadotropin-releasing hormone agonist (GnRHa) treatment for in vitro fertilization and Follicular fluid sialic acid levels are measured.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients who become pregnant
Time Frame: during procedure
Number of patients who become pregnant will be recorded
during procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Berna Aslan A Çetin, KSSTRH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2014

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

November 10, 2018

First Submitted That Met QC Criteria

November 16, 2018

First Posted (Actual)

November 19, 2018

Study Record Updates

Last Update Posted (Actual)

February 26, 2019

Last Update Submitted That Met QC Criteria

February 24, 2019

Last Verified

November 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • 2014.1.1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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