AMHR2 Polymorphism in Blood and Granulosa Cells in Unexplained Infertility

NCT05592730 | Unknown

• 1 other identifier: 09.06.2022-E.65396
• Study Type: observational
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Infertility, Female; AMH; IVF

Keywords

unexplained infertility; anti-mullerian hormone receptor2 polymorphism

Outcome Measures

Primary Outcomes (1)

• Ovarian response

  Number of oocytes, 5th day blast rate

  average of 6 months

Secondary Outcomes (1)

• Ongoing pregnancy rate

  average of 9 months

Study Arms (3)

Study Group

Patients with Unexplained İnfertility

Genetic: AMHR2 polymorphism in blood; Genetic: AMHR2 polymorphism in granulosa cell

First Control Group

Healthy Multiparous Women

Genetic: AMHR2 polymorphism in blood

Second Control Group

A: Patients with male infertility B: Patients with tubal factor

Genetic: AMHR2 polymorphism in blood; Genetic: AMHR2 polymorphism in granulosa cell

Interventions

AMHR2 polymorphism in blood GENETIC

1 tube of blood taken at the first application

First Control Group; Second Control Group; Study Group

AMHR2 polymorphism in granulosa cell GENETIC

Extraction of granulosa cell from the follicle fluid obtained during OPU

Second Control Group; Study Group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Unexplained infertility group

You may qualify if:

• 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

You may not qualify if:

• Patients with moderate/severe endometriosis (stage III and IV)
• previous ovarian surgery or underwent chemo/radiotherapy

Sponsors & Collaborators

• Bezmialem Vakif University: lead

Study Sites (1)

Bezmialem Vakif University

Istanbul, Turkey (Türkiye)

RECRUITING

Related Publications (3)

• 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.

  PMID: 24271023 BACKGROUND

• 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.

  PMID: 25790842 BACKGROUND

• 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.

  PMID: 27142041 BACKGROUND

MeSH Terms

Conditions

Infertility, Female

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Infertility

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Pinar Ozcan, MD, PhD

  BEZMİALEM VAKIF ÜNİVERSİTESİ

  STUDY CHAIR

Central Study Contacts

Pinar Ozcan, MD,PhD

CONTACT

+905414031625; pinarozcan@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2022
• First Posted: October 25, 2022
• Study Start: October 1, 2022
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: May 6, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)