- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05592730
AMHR2 Polymorphism in Blood and Granulosa Cells in Unexplained Infertility
Antimullerian Hormone Receptor 2 Polymorphism in Blood and Granulosa Cells in Unexplained Infertility
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This prospective, controlled cohort study was conducted at IVF Centre of Department of Obstetrics and Gynecology, Bezmialem University Hospital between October 2022 and April 2023. The study protocol was approved by the Ethical Committee of the Medical Faculty of Bezmialem University. Written informed consent was obtained from all patients. This trial was designed and reported according to the Consolidated Standards of Reporting Trials (CONSORT) guidelines.
The patients were divided into 3 groups. Group 1 (study group; unexplained infertilitiy, n=32), Group 2 ( first control group; healthy women with a history of at least one successful previous pregnancy, n=32), Group 3 ( second control group; infertile patients undergo IVF because of male or tubal factor, n=32). Inclusion criteria for the study were as follows: <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 and commencing IVF treatment. Patients with moderate/severe endometriosis (stage III and IV), previous ovarian surgery or underwent chemo/radiotherapy excluded from the study.
At the first application, peripheral blood will be taken from the Study group, 1st Control and 2nd Control group to evaluate polymorphisms of the AMHR2-482A>G(rs200255) with PCR analysis. During IVF treatment at the day of ovum pick up; follicular fluid will be collected to isolate granulosa cell for polymorphisms of the AMHR2-482A>G(rs200255) with PCR analysis.
The total number of embryos, the number of embryos transferred, the number of frozen and viable embryos will be recorded. After the embryo transfer is performed in the study group and the 2nd control group, the pregnancy results will be recorded by checking the bhcg in the blood on the 10-12th day of the transfer.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Pinar Ozcan, MD,PhD
- Phone Number: +905414031625
- Email: pinarozcan@hotmail.com
Study Locations
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-
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Istanbul, Turkey
- Recruiting
- Bezmialem Vakif University
-
Contact:
- Pinar Ozcan, MD, PhD
- Phone Number: +905414031625
- Email: drpinarozcan@hotmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Study Group
Patients with Unexplained İnfertility
|
1 tube of blood taken at the first application
Extraction of granulosa cell from the follicle fluid obtained during OPU
|
First Control Group
Healthy Multiparous Women
|
1 tube of blood taken at the first application
|
Second Control Group
A: Patients with male infertility B: Patients with tubal factor
|
1 tube of blood taken at the first application
Extraction of granulosa cell from the follicle fluid obtained during OPU
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Ovarian response
Time Frame: average of 6 months
|
Number of oocytes, 5th day blast rate
|
average of 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Ongoing pregnancy rate
Time Frame: average of 9 months
|
Pregnancies that continue until the 12th week of pregnancy
|
average of 9 months
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Pinar Ozcan, MD, PhD, BEZMİALEM VAKIF ÜNİVERSİTESİ
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 09.06.2022-E.65396
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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