Infertility, FemaleNCT05592730
AMHR2 Polymorphism in Blood and Granulosa Cells in Unexplained Infertility
An observational study of Infertility, Female and AMH, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility, Female, AMH, IVF
- What is being tested?
- AMHR2 polymorphism in blood and AMHR2 polymorphism in granulosa cell
- How many people
- 96 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2022to 1 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Unexplained infertility group
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- Patients with moderate/severe endometriosis (stage III and IV)
- previous ovarian surgery or underwent chemo/radiotherapy
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Bezmialem Vakif University
Istanbul
Pinar Ozcan, MD, PhD, +905414031625, drpinarozcan@hotmail.com
About this study
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.
Read the 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.
- Conditions
- Infertility, Female, AMH, IVF
- Being tested
- AMHR2 polymorphism in blood, AMHR2 polymorphism in granulosa cell
- Keywords
- unexplained infertility, anti-mullerian hormone receptor2 polymorphism
- Medical subject headings
- Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AMHR2 polymorphism in bloodGenetic
1 tube of blood taken at the first application
AMHR2 polymorphism in granulosa cellGenetic
Extraction of granulosa cell from the follicle fluid obtained during OPU
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Patients with Unexplained İnfertility Receives: Genetic: AMHR2 polymorphism in blood; Genetic: AMHR2 polymorphism in granulosa cell | |
| First Control Group | Healthy Multiparous Women Receives: Genetic: AMHR2 polymorphism in blood | |
| Second Control Group | A: Patients with male infertility B: Patients with tubal factor Receives: Genetic: AMHR2 polymorphism in blood; Genetic: AMHR2 polymorphism in granulosa cell |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ovarian response
Number of oocytes, 5th day blast rate
Measured: average of 6 months
Secondary outcomes (1)
Ongoing pregnancy rate
Pregnancies that continue until the 12th week of pregnancy
Measured: average of 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2022
- Study start1 Oct 2022
- Primary completion1 Dec 2023 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Infertility, FemaleStudies of the same condition, open and under way.
- More trials run by Bezmialem Vakif UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pinar Ozcan, MD, PhD, Study chair, BEZMİALEM VAKIF ÜNİVERSİTESİ
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05592730
- Sponsor's protocol ID
- 09.06.2022-E.65396
- Status last verified
- May 2023
- First submitted
- 20 Oct 2022
- Last updated
- 6 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 24271023Peluso 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.
PubMed 25790842Cerra 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.
PubMed 27142041
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antimullerian Hormone Receptor 2 Polymorphism in Blood and Granulosa Cells in Unexplained Infertility
- ClinicalTrials.gov ID
- NCT05592730
- Acronym / sponsor ID
- 09.06.2022-E.65396
- Conditions
- Infertility, Female, AMH, IVF
- Keywords
- unexplained infertility, anti-mullerian hormone receptor2 polymorphism
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 25 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Study Group | – | Genetic: AMHR2 polymorphism in blood, Genetic: AMHR2 polymorphism in granulosa cellPatients with Unexplained İnfertility |
| First Control Group | – | Genetic: AMHR2 polymorphism in bloodHealthy Multiparous Women |
| Second Control Group | – | Genetic: AMHR2 polymorphism in blood, Genetic: AMHR2 polymorphism in granulosa cellA: Patients with male infertility B: Patients with tubal factor |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Unexplained infertility group
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (2 listed)
- Patients with moderate/severe endometriosis (stage III and IV)
- previous ovarian surgery or underwent chemo/radiotherapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AMHR2 polymorphism in blood1 tube of blood taken at the first application | Genetic | First Control Group, Second Control Group, Study Group |
| AMHR2 polymorphism in granulosa cellExtraction of granulosa cell from the follicle fluid obtained during OPU | Genetic | Second Control Group, Study Group |
Primary outcome
Ovarian response
Time frame: average of 6 months
Number of oocytes, 5th day blast rate
1 secondary outcome
Ongoing pregnancy rate
Time frame: average of 9 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2023.
- Background: PubMed 24271023Yoshida 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.
- Background: PubMed 25790842Peluso 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.
- Background: PubMed 27142041Cerra 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pinar Ozcan, MD, PhD study chair
BEZMİALEM VAKIF ÜNİVERSİTESİ
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility, Female and AMH, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pinar Ozcan, MD,PhD (+905414031625, pinarozcan@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ovarian response (time frame: average of 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05592730, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2023.