Soluble Fms-like Tyrosine Kinase-1, Proangiogenic Protein Placental Growth Factor, and Niacin Levels in Women With Premature Ovarian Insufficiency
Conditions: Premature Ovarian Insufficiency
Sponsor: Cengiz Gokcek Women's and Children's Hospital

Full study protocol and statistical 
analysis plan 
Official Title of the study: 
Soluble fms-like tyrosine kinase-1, proangiogenic protein placental growth factor, and niacin 
levels in women with premature ovarian insufficiency 
 
Date of the document: 
November 2020. 
Contents: 
1. Participant Flow 
2. Baseline Characteristics 
3. Outcome Measures 
4.Endpoints of the study 
5.Limitations and Strengths 
6. Certain Agreements 
7. Results Point of Contact  
 
1. Participant Flow 
Recruitment Details 
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. We 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.  
Pre‐assignment Details 
The authors first will be assessed the recruited people to ensure meeting the inclusion and 
exclusion criteria. The inclusion criteria will be made according to the official documents. 
Arm/Group Information * 
 
There are two groups in the study. 

 
Arm/Group Title * 
 
Premature ovarian insufficiency group 
Control group 
2. Baseline Characteristics 
Power analysis could not be performed since there was no research on POI with these three 
markers in the literature. Kolmogorov Smirnov and Shapiro Wilk tests will be used to test the 
normal distribution of data. For comparing groups (POI/control) the student t-test will be used 
for variables that have a normal distribution, and the Mann Whitney U test will be used for 
variables that have not a normal distribution. The ROC analysis will be applied for the 
determination of cut-off point for variables. Moreover, Spearman correlation test will be used 
for the relationship of between variables. SPSS for Windows 22.0 and Medcalc programs will 
be used for statistical analysis. p<0.05 will be accepted as statistical significance.   
 
3. Outcome Measures 
 
Primary Outcome Measures: Soluble fms-like tyrosine kinase-1, proangiogenic protein 
placental growth factor, and niacin concentrations  
 
4. Endpoints of the study:  
The primary outcome in these analyses will compare serum soluble fms-like tyrosine kinase-
1, proangiogenic protein placental growth factor, and niacin levels in study group and control 
group. 
 
5.Limitations and strengths: 
There will strengths of this study. The women participating in the study had idiopathic POI 
and had not received treatment. 
6. Certain Agreements 
 
The authors declare that they have no conflict of interest. 
7. Results Point of Contact 
Corresponding Author: Ali Ovayolu, Department of Obstetrics and Gynecology, Cengiz 
Gokcek Women's and Children's Hospital, Gaziantep, Turkey, drovayolu@yahoo.com 

Address: Osmangazi Mahallesi, Cengiz Gokcek Kadın Hastaliklari ve Dogum Hastanesi, 
27010 Gaziantep, Turkey 
GSM: +90 (532) 640 40 60 
Tel.: +90.342 360 08 88 
Fax: +90.342 360 02 90