Follicular Fluid Sialic Acid Levels in IVF Cycles

Sponsor

Kanuni Sultan Suleyman Training and Research Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT03745027

Collaborator

(none)

Enrollment

Location

Arm

Actual Duration (Months)

3.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
in Vitro Fertilization	Diagnostic Test: in vitro fertilization	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

87 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Follicular Fluid Sialic Acid Levels in in Vitro Fertilization Cycles

Actual Study Start Date :

Jan 1, 2014

Actual Primary Completion Date :

Jan 1, 2016

Actual Study Completion Date :

Jan 1, 2016

Arms and Interventions

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.	Diagnostic Test: in vitro fertilization All patients underwent gonadotropin-releasing hormone agonist (GnRHa) treatment for in vitro fertilization and Follicular fluid sialic acid levels are measured.

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.

Diagnostic Test: in vitro fertilization

All patients underwent gonadotropin-releasing hormone agonist (GnRHa) treatment for in vitro fertilization and Follicular fluid sialic acid levels are measured.

Outcome Measures

Primary Outcome Measures

Number of patients who become pregnant [during procedure]
Number of patients who become pregnant will be recorded

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kanuni SSRTH	Istanbul		Turkey	34303

Sponsors and Collaborators

Kanuni Sultan Suleyman Training and Research Hospital

Investigators

Principal Investigator: Berna Aslan A Çetin, KSSTRH

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Berna Aslan Cetin, Md, ObGYN, Principal Investigator, Kanuni Sultan Suleyman Training and Research Hospital

ClinicalTrials.gov Identifier:

NCT03745027

Other Study ID Numbers:

2014.1.1

First Posted:

Nov 19, 2018

Last Update Posted:

Feb 26, 2019

Last Verified:

Nov 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Berna Aslan Cetin, Md, ObGYN, Principal Investigator, Kanuni Sultan Suleyman Training and Research Hospital

in vitro fertilization

sialic acid

Study Results

No Results Posted as of Feb 26, 2019