sFlt- 1, PIGF, and Niacin Levels in Women With Premature Ovarian Insufficiency

NCT04641624 | Completed

• 1 other identifier: CengizGWCH11
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Premature Ovarian Insufficiency

Outcome Measures

Primary Outcomes (3)

• sFlt- 1 levels

  The primary outcome measure in this analysis will compare sFlt- 1 levels in the idiopathic POI group and control group.

  1 week

• PIGF levels

  The primary outcome measure in this analysis will compare PIGF levels in the idiopathic POI group and control group.

  1 week

• niacin levels

  The primary outcome measure in this analysis will compare niacin levels in the idiopathic POI group and control group.

  1 week

Study Arms (2)

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.

Other: ultrasound assessment

Control group

45 patients with normal healthy women as control group.

Other: ultrasound assessment

Interventions

ultrasound assessment OTHER

soluble fms-like tyrosine kinase-1, proangiogenic protein placental growth factor, and niacin measurementswith a commercially available enzyme-linked immunosorbent assay (ELISA) kit.

Also known as: soluble fms-like tyrosine kinase-1, proangiogenic protein placental growth factor, and niacin measurements

Control group; Premature ovarian insufficiency (POI)

Eligibility Criteria

• Age: 18 Years - 39 Years
• Gender Eligibility Details: 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. It is estimated to affect 1% of women under the age of 40, 0.1% under 30 and 0.01% under 20.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

The investigators consecutively will be recruited 45 subjects with POI, and 45 healthy women will be selected for the control group.

You may qualify if:

• women with POI
• Healthy women

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Cengiz Gokcek Women's and Children's Hospital: lead

Study Sites (1)

Cengiz Gokcek Women's and Child's hospital

Gaziantep, 27010, Turkey (Türkiye)

Location

Related Publications (5)

• 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.

  PMID: 27008889 RESULT

• Wang 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.

  PMID: 30415247 RESULT

• Maclaran 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.

  PMID: 20424285 RESULT

• Taraseviciene 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.

  PMID: 27940029 RESULT

• Ovayolu 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.

  PMID: 36682889 DERIVED

MeSH Terms

Conditions

Primary Ovarian Insufficiency

Condition Hierarchy (Ancestors)

Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 18, 2020
• First Posted: November 24, 2020
• Study Start: November 20, 2020
• Primary Completion: June 30, 2021
• Study Completion: August 30, 2021
• Last Updated: August 31, 2021

Record last verified: 2021-08

Locations

TU (1)