Status:

UNKNOWN

Role of Nesfatin-1 and Nicotinamide in Infertile Women With Polycystic Ovary Syndrome

Lead Sponsor:

Assiut University

Conditions:

PCOS

Eligibility:

FEMALE

18-40 years

Brief Summary

evaluation of the potential role of circulating Nesfatin-1 and Nicotinamide in patients with polycystic ovary syndrome. and detection the correlation between Nesfatin-1 and body mass index (BMI), Wai...

Detailed Description

* Nesfatin-1 is an 82-amino acid polypeptide derived from the nucleobindin 2 (NUCB2) precursor proteins. * It is a newly identified peptide. It is released from several tissues including forebrain, hi...

Eligibility Criteria

Inclusion

  • PCOS patients in the age range 18 - 40 years old.
  • Diagnosis of PCOS is based on the 2003 ESHRE/ASRM diagnostic criteria, according to which patients who had at least two of the following conditions are accepted as having PCOS:
  • Oligo or anovulation, defined by the presence of oligomenorrhea or amenorrhea, confirmed by luteal progesterone and normal serum follicle stimulating hormone (FSH) levels (1.0-10.0 IU/L).
  • Clinical hyperandrogenism signs which was defined as the presence of at least one of the following three features: hirsutism, acne, and androgenic alopecia. Biochemical hyperandrogenism was defined as a serum testosterone (T) level \>60 ng/dL (\>2.08 nmol/L).
  • PCOS manifestation was defined as the presence of \>12 unilateral follicles 2-9 mm in size on the ovary or having the least unilateral ovary volume of 10 cm3 by ultrasonography (the measurement was performed when there was no follicle \>10 mm). Ovarian volume was calculated by the formula \[0.5× ovarian length × thickness × width\]. In the case of transabdominal ultrasonography, the presence of at least 10 unilateral antral follicles was required.

Exclusion

  • Patients (age \<18 or \> 40years),
  • Other endocrinology diseases as diabetes mellitus or thyroid disorders, Brain disorders as pituitary adenoma or tumour or brain tumours or masses,
  • Chronic diseases such as cardiovascular, hepatic, hematologic, chronic renal failure, hypertension, and cancer,
  • Use of oral contraceptives, antiandrogenics, glucocorticoids, antihypertensives, antidiabetics and anti-obesity drugs as well as the cigarettes, alcohol, and patients unwilling to participate in the study.

Key Trial Info

Start Date :

May 1 2019

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

May 1 2020

Estimated Enrollment :

56 Patients enrolled

Trial Details

Trial ID

NCT03870035

Start Date

May 1 2019

End Date

May 1 2020

Last Update

April 26 2019

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