Infertility, Female Clinical Trial
Official title:
Antimullerian Hormone Receptor 2 Polymorphism in Blood and Granulosa Cells in Unexplained Infertility
There are various known parameters for assessing ovarian reserve, including ovarian volume, antral follicle count, follicle stimulating hormone (FSH) and Inhibin B at the beginning of the menstrual cycle, as well as anti-Mullerian hormone (AMH). Anti-müllerian hormone is a dimeric glycoprotein and a member of the transforming growth factor β family that plays a role in the regulation of follicular development. AMH is produced by granulosa cells of the early developing follicles in the ovary, and continues to be expressed in the growing follicles until these follicles have reached a size of 4-6 mm and a differentiation state at which AMH becomes receptive for exogenous FSH, and may be selected for dominance.It exerts its biological effects through the receptor AMHR2, which is present on granulosa and theca cells. Considering the important role of the AMH signalling pathway in regulating FSH sensitivity in the ovary and follicular recruitment and selection, it is appropriate to consider that variation in the genes encoding key proteins in the pathway may influence ovarian response. The aim of this study is to investigate the effect of the distribution of single gene polymorphisms of the AMHR2 receptor gene A-482G/rs200255 in patients with unexplained infertility and to compare this distribution with the distribution in women without infertility.
Status | Recruiting |
Enrollment | 96 |
Est. completion date | December 1, 2023 |
Est. primary completion date | December 1, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 40 Years |
Eligibility | inclusion criteria - unexplained infertility (study group) - a healthy women with a history of at least one successful previous pregnancy resulting from spontaneous conception (first control group) - infertility caused by male factor, tubal factor (second control group) - <40 years of age - normal serum levels of TSH and prolactin - presence of both ovaries without any morphological abnormalities - normal ovulatory cycles (25-35 days) - body mass index (BMI) =30 - no previous history of poor response and no evidence of endocrine disease, such as polycystic ovary syndrome, hipo-hyper prolactinemia - no use of hormone therapy in the 6 months preceding the recruitment - undergoing IVF exclusion criteria - Patients with moderate/severe endometriosis (stage III and IV) - previous ovarian surgery or underwent chemo/radiotherapy |
Country | Name | City | State |
---|---|---|---|
Turkey | Bezmialem Vakif University | Istanbul |
Lead Sponsor | Collaborator |
---|---|
Bezmialem Vakif University |
Turkey,
Cerra C, Newman WG, Tohlob D, Byers H, Horne G, Roberts SA, Mohiyiddeen L. AMH type II receptor and AMH gene polymorphisms are not associated with ovarian reserve, response, or outcomes in ovarian stimulation. J Assist Reprod Genet. 2016 Aug;33(8):1085-91. doi: 10.1007/s10815-016-0711-7. Epub 2016 May 3. — View Citation
Peluso C, Fonseca FL, Gastaldo GG, Christofolini DM, Cordts EB, Barbosa CP, Bianco B. AMH and AMHR2 polymorphisms and AMH serum level can predict assisted reproduction outcomes: a cross-sectional study. Cell Physiol Biochem. 2015;35(4):1401-12. doi: 10.1159/000373961. Epub 2015 Mar 12. — View Citation
Yoshida Y, Yamashita Y, Saito N, Ono Y, Yamamoto H, Nakamura Y, Hayashi A, Terai Y, Ohmichi M. Analyzing the possible involvement of anti-Mullerian hormone and anti-Mullerian hormone receptor II single nucleotide polymorphism in infertility. J Assist Reprod Genet. 2014 Feb;31(2):163-8. doi: 10.1007/s10815-013-0134-7. Epub 2013 Nov 24. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Ovarian response | Number of oocytes, 5th day blast rate | average of 6 months | |
Secondary | Ongoing pregnancy rate | Pregnancies that continue until the 12th week of pregnancy | average of 9 months |
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