InfertilityNCT04201847
Follicular Fluid Fetuins in in Vitro Fertilization
A study testing Serum test in people with Infertility and Infertility, Female, run by Samsun Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Infertility, Infertility, Female
- What is being tested?
- Serum test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 May 2018to 20 Oct 2019
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Poor ovarian reserve patients and patient with polycystic ovary syndrome
Who cannot join
- Normoresponders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Follicular Fetuin A and Fetin B Levels Are Associated With Clinical Pregnancy and Live Birth Rates in IVF Cycles
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)
- Conditions
- Infertility, Infertility, Female
- Being tested
- Serum test
- Medical subject headings
- Infertility, Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serum testDiagnostic test
Also called FOLLICULAR FETUIN B LEVELS IN IVF
Serum Fetuin A and fetuin B
| Study group | Role | What they receive |
|---|---|---|
| Infertile women with normal ovarian reserve | Active comparator | Infertile women with normal ovarian reserve will be included. Receives: Diagnostic Test: Serum test |
| Infertile women with high ovarian reserve | Active comparator | Infertile women with high ovarian reserve will be included. Receives: Diagnostic Test: Serum test |
| Infertile women with poor ovarian reserve | Active comparator | Infertile women with poor ovarian reserve will be included. Receives: Diagnostic Test: Serum test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2019
- Study start20 May 2018
- Primary completion25 Feb 2019
- Study completion20 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsun Education and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samettin Çelik, Samsun Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04201847
- Sponsor's protocol ID
- KAEK-2019/4/27
- Status last verified
- Nov 2020
- First submitted
- 13 Dec 2019
- Last updated
- 6 Nov 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Follicular Fetuin A and Fetin B Levels Are Associated With Clinical Pregnancy and Live Birth Rates in IVF Cycles
- ClinicalTrials.gov ID
- NCT04201847
- Acronym / sponsor ID
- KAEK-2019/4/27
- Conditions
- Infertility, Infertility, Female
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Samsun Education and Research HospitalUniversity, hospital or other
- Study start
- 20 May 2018 (actual)
- Primary completion
- 25 Feb 2019 (actual)
- Study completion
- 20 Oct 2019 (actual)
- First posted
- 17 Dec 2019 (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 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)
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Infertile women with normal ovarian reserve | Active comparator | Diagnostic Test: Serum testInfertile women with normal ovarian reserve will be included. |
| Infertile women with high ovarian reserve | Active comparator | Diagnostic Test: Serum testInfertile women with high ovarian reserve will be included. |
| Infertile women with poor ovarian reserve | Active comparator | Diagnostic Test: Serum testInfertile women with poor ovarian reserve will be included. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Poor ovarian reserve patients and patient with polycystic ovary syndrome
Key exclusion criteria (1 listed)
- Normoresponders
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 |
|---|---|---|
| Serum testAlso: FOLLICULAR FETUIN B LEVELS IN IVFSerum Fetuin A and fetuin B | Diagnostic test | Infertile women with high ovarian reserve, Infertile women with normal ovarian reserve, Infertile women with poor ovarian reserve |
Primary outcome
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.
Time frame: 4 weeks
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.
Time frame: 8 weeks
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.
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 6 Nov 2020.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Serum test in people with Infertility and Infertility, Female, run by Samsun Education 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 1 inclusion and 1 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 6 Nov 2020. 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?
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. (time frame: 4 weeks). The study lists 2 primary outcomes in all. 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 6 Nov 2020.