Azerbaijani
Albanian
Arabic
Armenian
Azerbaijani
Belarusian
Bengali
Bosnian
Catalan
Czech
Danish
Deutsch
Dutch
English
Estonian
Finnish
Français
Greek
Haitian Creole
Hebrew
Hindi
Hungarian
Icelandic
Indonesian
Irish
Italian
Japanese
Korean
Latvian
Lithuanian
Macedonian
Mongolian
Norwegian
Persian
Polish
Portuguese
Romanian
Russian
Serbian
Slovak
Slovenian
Spanish
Swahili
Swedish
Turkish
Ukrainian
Vietnamese
Български
中文(简体)
中文(繁體)

Vitamin D and Polycystic Ovarian Syndrome

Yalnız qeydiyyatdan keçmiş istifadəçilər məqalələri tərcümə edə bilərlər
Giriş / Qeydiyyatdan keçin
Bağlantı panoya saxlanılır
StatusHələ işə qəbul edilmir
Sponsorlar
Aga Khan University

Açar sözlər

Mücərrəd

Primary Objectives:
To evaluate the efficacy of metformin and Vitamin D supplementation on serum insulin and serum androgen levels (Total testosterone, Steroid Hormone Binding Globulin, Free Androgen Index) levels compared metformin alone in infertile Poly cystic ovarian females of reproductive age group.
Secondary Objectives:
To measure change in endometrial thickness/number of follicles and follicular size by day 12 trans-vaginal ultrasound in the intervention group i.e. combination of metformin and vitamin D supplementation

Təsvir

Polycystic ovary syndrome (PCOS) as defined by "the presence of any two out of three criteria i.e. Oligo and/or anovulation, excess androgen activity and/or polycystic ovarian morphology on ultrasound", is a prevalent cause of female infertility. In the endocrine milieu of PCOS higher levels of insulin due to insulin resistance (IR) exert direct effects on the ovaries, release insulin-like growth factor 1 (IGF-1) from the liver and both then increase levels of testosterone. The resultant prevents the growth of ovarian follicles to acquire the required dimension for ovulation (i.e. > 10 mm) hence leading to anovulation and therefore subfertility. Vitamin D (VD) has found to be predominantly deficient in PCOS females, documented to cause IR giving rise to anovulatory cycles, hyperandrogenism and other significant features of PCOS. Therefore, we have hypothesized that treatment with VD in PCOS females can reduce IR, improve ovulation and signs of hyperandrogenism. Since Metformin is frequently prescribed for reducing IR and hence the treatment for anovulatory infertility in these females, we have planned to conduct an open label randomized control trial in PCOS infertile females who have vitamin D levels < than 25 ng/ml and are receiving Metformin therapy after ethical approval from Aga Khan University. The intervention group will receive VD Cholecalciferol (D2) 50,000 I.U once weekly for 12 weeks, followed by 50,000 I.U once every fortnight for 24 weeks with the Metformin treatment as prescribed by the physician whereas control group will receive Metformin treatment during the study period. We will compare change in number of dominant follicles (more than 10 mm) / endometrial thickness in both groups by Day 12 trans-vaginal ultrasound at the time of enrollment with scans done after 12 and 24 weeks. The other biochemical parameters [Total Testosterone, Steroid Hormone Binding Globulin, Free Androgen Index, Lipid accumulation product LAP , serum Insulin, C Reactive Protein (hs-CRP) Serum Triglycerides, serum calcium and albumin] will be done at the time of recruitment in both the intervention and control groups and compared

Tarixlər

Son Doğrulandı: 05/31/2019
İlk təqdim: 06/12/2019
Təxmini qeydiyyat təqdim edildi: 06/16/2019
İlk Göndərmə: 06/17/2019
Son Yeniləmə Göndərildi: 06/16/2019
Son Yeniləmə Göndərildi: 06/17/2019
Həqiqi Təhsilin Başlama Tarixi: 12/31/2019
Təxmini İlkin Tamamlanma Tarixi: 12/30/2021
Təxmini İşin Tamamlanma Tarixi: 06/12/2022

Vəziyyət və ya xəstəlik

Infertility, Female
Infertility
Vitamin D Deficiency

Müdaxilə / müalicə

Drug: Vitamin D supplement

Faza

Faza 2

Qol Qrupları

QolMüdaxilə / müalicə
Experimental: Vitamin D supplement
he intervention group will receive VD Cholecalciferol (D2) 50,000 I.U once weekly for 12 weeks, followed by 50,000 I.U once every fortnight for 24 weeks with the Metformin treatment as prescribed by the physician whereas
Drug: Vitamin D supplement
Vitamin D supplementation
No Intervention: Control
control group will receive Metformin treatment during the study period.

Uyğunluq Kriteriyaları

Təhsil üçün uyğun yaşlar 18 Years Üçün 18 Years
Təhsilə Uyğun CinslərAll
Sağlam Könüllüləri qəbul edirBəli
Kriteriyalar

Inclusion Criteria:

- Females with age range 18- 36 years, from all ethnic background having primary infertility with diagnosis of PCOS when at least 2 of these 3 elements are present: hyperandrogenism, chronic anovulation and polycystic ovaries and Vitamin D deficiency serum levels < 25 nmol/L

Exclusion Criteria:

exclusion criteria at baseline will be excluded from the study

- Females with secondary Infertility

- Hypercalcemia (plasma calcium concentrations> 2.65 mmol/L)

- Exclude women with Tuberculosis or other granulomatous disorders.

- Women receiving vitamin D replacement, oral contraceptives, hormonal replacement therapy, glucocorticoids, calcium supplementation, insulin-sensitizing drugs(incretin mimetic drugs, thiazolidinedione, sulfonylurea), lipid-lowering drugs or other drugs affecting insulin sensitivity or serum androgens (e.g., niacin, corticosteroids, beta-blockers, calcium channel blockers, thiazide diuretics), anti-epileptics, anti-retroviral, cholestyramine, anti-fungal, statins, H2 blockers, immunosuppressants, chemotherapeutic agents, antimicrobials (Rifampicin, isoniazid, hydroqychloroquin) or any other drug modifying lipid metabolism in the previous 3 months prior to study

- Women with congenital adrenal hyperplasia, Cushing's syndrome, androgen-secreting tumors, type 2 diabetes mellitus, renal, hepatic or thyroid disorders, hyperparathyroidism, malabsorption syndromes, Chronic Kidney Disease Hepatic failure, cystic fibrosis, vaginal bleeding of unknown etiology Women Those who had Bariatric surgery will also be excluded.

Nəticə

İlkin nəticə tədbirləri

1. • Insulin levels [24 weeks]

Decrease in insulin levels 60%

2. • serum androgen levels [24 weeks]

Decrease in Serum Androgen levels

İkincili Nəticə Tədbirləri

1. Endometrial thickness [24 weeks]

increase in endometrial thickness to 2mm

2. Lipid Accumulation Product [24 weeks]

reduction in LAP

Facebook səhifəmizə qoşulun

Elm tərəfindən dəstəklənən ən tam dərman bitkiləri bazası

  • 55 dildə işləyir
  • Elm tərəfindən dəstəklənən bitki mənşəli müalicələr
  • Təsvirə görə otların tanınması
  • İnteraktiv GPS xəritəsi - yerdəki otları etiketləyin (tezliklə)
  • Axtarışınızla əlaqəli elmi nəşrləri oxuyun
  • Təsirlərinə görə dərman bitkilərini axtarın
  • Maraqlarınızı təşkil edin və xəbər araşdırmaları, klinik sınaqlar və patentlər barədə məlumatlı olun

Bir simptom və ya bir xəstəlik yazın və kömək edə biləcək otlar haqqında oxuyun, bir ot yazın və istifadə olunan xəstəliklərə və simptomlara baxın.
* Bütün məlumatlar dərc olunmuş elmi araşdırmalara əsaslanır

Google Play badgeApp Store badge