Premature Ovarian InsufficiencyPOİ&niacinNCT04641624
sFlt- 1, PIGF, and Niacin Levels in Women With Premature Ovarian Insufficiency
An observational study of Premature Ovarian Insufficiency, run by Cengiz Gokcek Women's and Children's Hospital at 1 site in Turkey (Türkiye).
Trial summary
Aim: To evaluate serum soluble fms-like tyrosine kinase-1, proangiogenic protein placental growth factor, and niacin levels in women with premature ovarian insufficiency (POI) and to compare the results with those of healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 39 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Premature Ovarian Insufficiency
- What is being tested?
- ultrasound assessment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Nov 2020to 30 Aug 2021
- Phase
- Observational
- 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 39 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: The investigators consecutively will be recruited 45 subjects with POI, and 45 healthy women will be selected for the control group.
Who may be able to join
- women with POI
- Healthy women
Who cannot join
- women with any systemic condition (such as chronic hypertension, renal disease)
- history of using any medication
- drug user
- history/presence of malignancy
- history of Radiotherapy/chemotherapy
- polycystic ovary syndrome
Show all 12Show fewer
- women who had any other acute/chronic infection or fever
- Patients whose chromosome analysis result is not normal
- history of ovarian surgery
- Ovarian cysts/mass
- pregnancy
- lactation
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Cengiz Gokcek Women's and Child's hospital
Gaziantep, 27010
About this study
Official title: Soluble Fms-like Tyrosine Kinase-1, Proangiogenic Protein Placental Growth Factor, and Niacin Levels in Women With Premature Ovarian Insufficiency
Aim: To evaluate serum soluble fms-like tyrosine kinase-1, proangiogenic protein placental growth factor, and niacin levels in women with premature ovarian insufficiency (POI) and to compare the results with those of healthy subjects.
Methods: This prospective study will be included 45 women with idiopathic premature ovarian insufficiency and 45 controls. The blood for analysis will be obtained at the early follicular phase of the menstrual cycle and serum soluble fms-like tyrosine kinase-1, proangiogenic protein placental growth factor, and niacin levels will be measured using a commercially available ELISA kit.
Read the detailed description
This will be an observational prospective cohort study conducted at Obstetrics and Gynecology Department of Cengiz Gokcek Obstetrics and Children's Hospital between November 2020 and April 2021. The investigators will be recruited 45 subjects with idiopathic POI, and 45 healthy patients were selected for the control group. All patients will be given their oral and written informed consent before their inclusion in the study. The protocol was approved by the Ethics Committee for Clinical Research of Gaziantep University (Reference number: 2020/320). The study strictly will be adhered to the principles of the Declaration of Helsinki.
Women between the ages of 18-39 will be included. A volunteer group of healthy women who will be visited the gynecology clinic for routine examinations and women who will be admitted for pre-pregnancy tests will be invited randomly to this research as a control group. Healthy women, who will be returned during their early follicular phase of the menstrual cycle, will be recruited as the control group subjects. The exclusion criteria will be as follows: women with evidence for karyotypic, metabolic, toxic, or iatrogenic cause of the ovarian insufficiency and any women who use any medication for POI treatment. At enrollment, for both groups, the investigators will be collected data about age, height, weight, BMI, age of menarche, obstetrics history, history of smoking, regular exercise and family history of POI. At enrolment, all patients will be underwent vaginal ultrasonography for the assessment of antral follicle count (AFC) and venous blood sample from the antecubital veins for measuring serum concentration of soluble fms-like tyrosine kinase-1, proangiogenic protein placental growth factor, and niacin, Follicle-stimulating hormone (FSH), E2, anti-mullerian hormone (AMH) and complete blood count (CBC). In control subjects venous blood samples and AFC will be collected during the early follicular phase of the menstrual cycle. The serum samples will be stored in aliquots at -80°C prior to the analyses of sFlt- 1, PIGF, and niacin. The serum soluble fms-like tyrosine kinase-1, proangiogenic protein placental growth factor, and niacin level will be measured using a commercially available enzyme-linked immunosorbent assay (ELISA) kit. Then, this study will be determined maternal serum soluble fms-like tyrosine kinase-1, proangiogenic protein placental growth factor, and niacin levels in women with POI (n=45) compared to those of volunteer healthy women (n=45). Then, these three markers levels will be compared in both group.
- Conditions
- Premature Ovarian Insufficiency
- Being tested
- ultrasound assessment
- Medical subject headings
- Primary Ovarian Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound assessmentOther
Also called soluble fms-like tyrosine kinase-1, proangiogenic protein placental growth factor, and niacin measurements
soluble fms-like tyrosine kinase-1, proangiogenic protein placental growth factor, and niacin measurementswith a commercially available enzyme-linked immunosorbent assay (ELISA) kit.
| Study group | Role | What they receive |
|---|---|---|
| Premature ovarian insufficiency (POI) | POI is a clinical syndrome defined by loss of ovarian activity before the age of 40 years. POI is characterized by menstrual disturbance (amenorrhea or oligomenorrhea) with raised gonadotrophins and low estradiol.
The study population will be consisted of 45 women with POI as study group. Receives: Other: ultrasound assessment | |
| Control group | 45 patients with normal healthy women as control group. Receives: Other: ultrasound assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
sFlt- 1 levels
The primary outcome measure in this analysis will compare sFlt- 1 levels in the idiopathic POI group and control group.
Measured: 1 week
PIGF levels
The primary outcome measure in this analysis will compare PIGF levels in the idiopathic POI group and control group.
Measured: 1 week
niacin levels
The primary outcome measure in this analysis will compare niacin levels in the idiopathic POI group and control group.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2020
- Study start20 Nov 2020
- Primary completion30 Jun 2021
- Study completion30 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Premature Ovarian InsufficiencyStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cengiz Gokcek Women's and Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Ovayolu, Cengiz Gokcek Women's and Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04641624
- Sponsor's protocol ID
- CengizGWCH11
- Acronym
- POİ&niacin
- Status last verified
- Aug 2021
- First submitted
- 18 Nov 2020
- Last updated
- 31 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
European Society for Human Reproduction and Embryology (ESHRE) Guideline Group on POI; Webber L, Davies M, Anderson R, Bartlett J, Braat D, Cartwright B, Cifkova R, de Muinck Keizer-Schrama S, Hogervorst E, Janse F, Liao L, Vlaisavljevic V, Zillikens C, Vermeulen N. ESHRE Guideline: management of women with premature ovarian insufficiency. Hum Reprod. 2016 May;31(5):926-37. doi: 10.1093/humrep/dew027. Epub 2016 Mar 22.
PubMed 27008889Wang S, Sun M, Yu L, Wang Y, Yao Y, Wang D. Niacin Inhibits Apoptosis and Rescues Premature Ovarian Failure. Cell Physiol Biochem. 2018;50(6):2060-2070. doi: 10.1159/000495051. Epub 2018 Nov 9.
PubMed 30415247Maclaran K, Horner E, Panay N. Premature ovarian failure: long-term sequelae. Menopause Int. 2010 Mar;16(1):38-41. doi: 10.1258/mi.2010.010014. No abstract available.
PubMed 20424285Taraseviciene V, Grybauskiene R, Maciuleviciene R. sFlt-1, PlGF, sFlt-1/PlGF ratio and uterine artery Doppler for preeclampsia diagnostics. Medicina (Kaunas). 2016;52(6):349-353. doi: 10.1016/j.medici.2016.11.008. Epub 2016 Nov 29.
PubMed 27940029Ovayolu A, Bostancieri N. A prospective and comparative investigation of blood sFlt-1, P1GF, and niacin concentrations in women with premature ovarian insufficiency. J Obstet Gynaecol Res. 2023 Apr;49(4):1198-1205. doi: 10.1111/jog.15554. Epub 2023 Jan 22.
PubMed 36682889
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Soluble Fms-like Tyrosine Kinase-1, Proangiogenic Protein Placental Growth Factor, and Niacin Levels in Women With Premature Ovarian Insufficiency
- ClinicalTrials.gov ID
- NCT04641624
- Acronym / sponsor ID
- POİ&niacin / CengizGWCH11
- Conditions
- Premature Ovarian Insufficiency
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Cengiz Gokcek Women's and Children's HospitalUniversity, hospital or other
- Study start
- 20 Nov 2020 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Aug 2021 (actual)
- First posted
- 24 Nov 2020 (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.
Aim: To evaluate serum soluble fms-like tyrosine kinase-1, proangiogenic protein placental growth factor, and niacin levels in women with premature ovarian insufficiency (POI) and to compare the results with those of healthy subjects.
Methods: This prospective study will be included 45 women with idiopathic premature ovarian insufficiency and 45 controls. The blood for analysis will be obtained at the early follicular phase of the menstrual cycle and serum soluble fms-like tyrosine kinase-1, proangiogenic protein placental growth factor, and niacin levels will be measured using a commercially available ELISA kit.
Detailed description
This will be an observational prospective cohort study conducted at Obstetrics and Gynecology Department of Cengiz Gokcek Obstetrics and Children's Hospital between November 2020 and April 2021. The investigators will be recruited 45 subjects with idiopathic POI, and 45 healthy patients were selected for the control group. All patients will be given their oral and written informed consent before their inclusion in the study. The protocol was approved by the Ethics Committee for Clinical Research of Gaziantep University (Reference number: 2020/320). The study strictly will be adhered to the principles of the Declaration of Helsinki.
Women between the ages of 18-39 will be included. A volunteer group of healthy women who will be visited the gynecology clinic for routine examinations and women who will be admitted for pre-pregnancy tests will be invited randomly to this research as a control group. Healthy women, who will be returned during their early follicular phase of the menstrual cycle, will be recruited as the control group subjects. The exclusion criteria will be as follows: women with evidence for karyotypic, metabolic, toxic, or iatrogenic cause of the ovarian insufficiency and any women who use any medication for POI treatment. At enrollment, for both groups, the investigators will be collected data about age, height, weight, BMI, age of menarche, obstetrics history, history of smoking, regular exercise and family history of POI. At enrolment, all patients will be underwent vaginal ultrasonography for the assessment of antral follicle count (AFC) and venous blood sample from the antecubital veins for measuring serum concentration of soluble fms-like tyrosine kinase-1, proangiogenic protein placental growth factor, and niacin, Follicle-stimulating hormone (FSH), E2, anti-mullerian hormone (AMH) and complete blood count (CBC). In control subjects venous blood samples and AFC will be collected during the early follicular phase of the menstrual cycle. The serum samples will be stored in aliquots at -80°C prior to the analyses of sFlt- 1, PIGF, and niacin. The serum soluble fms-like tyrosine kinase-1, proangiogenic protein placental growth factor, and niacin level will be measured using a commercially available enzyme-linked immunosorbent assay (ELISA) kit. Then, this study will be determined maternal serum soluble fms-like tyrosine kinase-1, proangiogenic protein placental growth factor, and niacin levels in women with POI (n=45) compared to those of volunteer healthy women (n=45). Then, these three markers levels will be compared in both group.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Premature ovarian insufficiency (POI) | – | Other: ultrasound assessmentPOI is a clinical syndrome defined by loss of ovarian activity before the age of 40 years. POI is characterized by menstrual disturbance (amenorrhea or oligomenorrhea) with raised gonadotrophins and low estradiol. The study population will be consisted of 45 women with POI as study group. |
| Control group | – | Other: ultrasound assessment45 patients with normal healthy women as control group. |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The investigators consecutively will be recruited 45 subjects with POI, and 45 healthy women will be selected for the control group.
Key inclusion criteria (2 listed)
- women with POI
- Healthy women
Key exclusion criteria (12 listed)
- women with any systemic condition (such as chronic hypertension, renal disease)
- history of using any medication
- drug user
- history/presence of malignancy
- history of Radiotherapy/chemotherapy
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 |
|---|---|---|
| ultrasound assessmentAlso: soluble fms-like tyrosine kinase-1, proangiogenic protein placental growth factor, and niacin measurementssoluble fms-like tyrosine kinase-1, proangiogenic protein placental growth factor, and niacin measurementswith a commercially available enzyme-linked immunosorbent assay (ELISA) kit. | Other | Control group, Premature ovarian insufficiency (POI) |
Primary outcome
sFlt- 1 levels
Time frame: 1 week
The primary outcome measure in this analysis will compare sFlt- 1 levels in the idiopathic POI group and control group.
PIGF levels
Time frame: 1 week
The primary outcome measure in this analysis will compare PIGF levels in the idiopathic POI group and control group.
niacin levels
Time frame: 1 week
The primary outcome measure in this analysis will compare niacin levels in the idiopathic POI group and control group.
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 31 Aug 2021.
- Results publication: PubMed 27008889European Society for Human Reproduction and Embryology (ESHRE) Guideline Group on POI; Webber L, Davies M, Anderson R, Bartlett J, Braat D, Cartwright B, Cifkova R, de Muinck Keizer-Schrama S, Hogervorst E, Janse F, Liao L, Vlaisavljevic V, Zillikens C, Vermeulen N. ESHRE Guideline: management of women with premature ovarian insufficiency. Hum Reprod. 2016 May;31(5):926-37. doi: 10.1093/humrep/dew027. Epub 2016 Mar 22.
- Results publication: PubMed 30415247Wang S, Sun M, Yu L, Wang Y, Yao Y, Wang D. Niacin Inhibits Apoptosis and Rescues Premature Ovarian Failure. Cell Physiol Biochem. 2018;50(6):2060-2070. doi: 10.1159/000495051. Epub 2018 Nov 9.
- Results publication: PubMed 20424285Maclaran K, Horner E, Panay N. Premature ovarian failure: long-term sequelae. Menopause Int. 2010 Mar;16(1):38-41. doi: 10.1258/mi.2010.010014. No abstract available.
- Results publication: PubMed 27940029Taraseviciene V, Grybauskiene R, Maciuleviciene R. sFlt-1, PlGF, sFlt-1/PlGF ratio and uterine artery Doppler for preeclampsia diagnostics. Medicina (Kaunas). 2016;52(6):349-353. doi: 10.1016/j.medici.2016.11.008. Epub 2016 Nov 29.
- Derived from this study: PubMed 36682889Ovayolu A, Bostancieri N. A prospective and comparative investigation of blood sFlt-1, P1GF, and niacin concentrations in women with premature ovarian insufficiency. J Obstet Gynaecol Res. 2023 Apr;49(4):1198-1205. doi: 10.1111/jog.15554. Epub 2023 Jan 22.
- Individual participant dataSharing planned: Undecided
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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?
An observational study of Premature Ovarian Insufficiency, run by Cengiz Gokcek Women's and Children's 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 2 inclusion and 12 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 31 Aug 2021. 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?
sFlt- 1 levels (time frame: 1 week). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04641624, which also lists 5 linked publications.
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 31 Aug 2021.