in Vitro FertilizationNCT03745027
Follicular Fluid Sialic Acid Levels in IVF Cycles
A study testing in vitro fertilization in people with in Vitro Fertilization, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- in Vitro Fertilization
- What is being tested?
- in vitro fertilization
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2014to 1 Jan 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- in Vitro Fertilization
- Being tested
- in vitro fertilization
- Keywords
- in vitro fertilization, sialic acid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
in vitro fertilizationDiagnostic test
All patients underwent gonadotropin-releasing hormone agonist (GnRHa) treatment for in vitro fertilization and Follicular fluid sialic acid levels are measured.
| Study group | Role | What they receive |
|---|---|---|
| In vitro fertilization | Experimental | Paients undergoing in vitro fertilization with Gonadotropin-releasing Hormone agonist. Follicular fluid sialic acid levels will be measured. Receives: Diagnostic Test: in vitro fertilization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients who become pregnant
Number of patients who become pregnant will be recorded
Measured: during procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2018
- Study start1 Jan 2014
- Primary completion1 Jan 2016
- Study completion1 Jan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for in Vitro FertilizationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Berna Aslan Cetin, Kanuni Sultan Suleyman Training and Research Hospital
- Investigators
- Berna Aslan A Çetin, Principal investigator, KSSTRH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03745027
- Sponsor's protocol ID
- 2014.1.1
- Status last verified
- Nov 2018
- First submitted
- 10 Nov 2018
- Last updated
- 26 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Follicular Fluid Sialic Acid Levels in in Vitro Fertilization Cycles
- ClinicalTrials.gov ID
- NCT03745027
- Acronym / sponsor ID
- 2014.1.1
- Conditions
- in Vitro Fertilization
- Keywords
- in vitro fertilization, sialic acid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 1 Jan 2016 (actual)
- Study completion
- 1 Jan 2016 (actual)
- First posted
- 19 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| In vitro fertilization | Experimental | Diagnostic Test: in vitro fertilizationPaients undergoing in vitro fertilization with Gonadotropin-releasing Hormone agonist. Follicular fluid sialic acid levels will be measured. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| in vitro fertilizationAll patients underwent gonadotropin-releasing hormone agonist (GnRHa) treatment for in vitro fertilization and Follicular fluid sialic acid levels are measured. | Diagnostic test | In vitro fertilization |
Primary outcome
Number of patients who become pregnant
Time frame: during procedure
Number of patients who become pregnant will be recorded
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2019.
- Individual participant dataSharing planned: Undecided
Related trials for in Vitro Fertilization
RecruitingObservational study
International Pilot Study for Dual Non-invasive Assesment of Embryo Development
Infertility
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Ubiquinone vs. Ubiquinol Supplementation
IVF
Recruiting
Trigger Timing in Ovarian Stimulations
IVF Outcome
Active, not recruiting
Automation of the In Vitro Fertilization Laboratory
Infertility, ART
RecruitingPhase 4
Study of G-CSF for DOR in Patients Undergoing IVF
Diminished Ovarian Reserve, IVF
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Berna Aslan A Çetin principal investigator
KSSTRH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing in vitro fertilization in people with in Vitro Fertilization, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients who become pregnant (time frame: during procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2019.