InfertilityNCT02436538
Correlation Between Serum Anti-Müllerian Hormone & Müllerian Ducts Anomalies in Infertility
An observational study of Infertility, run by Ahmed M.Kamel at 1 site in Egypt.
Trial summary
Anti-Müllerian hormone (AMH), also known as Müllerian inhibiting substance, is a dimeric glycoprotein that belongs to the transforming growth factor-beta family. It is involved in the regression of the Müllerian ducts during male fetal development. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility
- What is being tested?
- Anti Mullerian hormone level; Mullerian duct anomaly type
- How many people
- 226 participants
- Where
- 1 siteEgypt
- Study dates
- Apr 2015to Nov 2016
- 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 20 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: female undergoing intraCytoplasmic sperm injection for treatment of infertility
Who may be able to join
- women with diagnosed mullerian anomlies whether clinically or through imaging
Who cannot join
- previous ovarian surgery
- ovarian drilling
- polycystic ovarian syndrome (PCOs).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Correlation Between Serum Anti-Müllerian Hormone (AMH) Levels & Müllerian Ducts Anomalies in Patients Undergoingintracytoplasmic Sperm Injection (ICSI)
Anti-Müllerian hormone (AMH), also known as Müllerian inhibiting substance, is a dimeric glycoprotein that belongs to the transforming growth factor-beta family. It is involved in the regression of the Müllerian ducts during male fetal development. In the female, AMH is solely produced by the granulosa cells of preantral and small antral follicles, and regulates ovarian activity and follicular steroidogenesis
Read the detailed description
Following approval of the internal review board of Egyptian IVF-ET center, a retrospective analysis will be undertaken where a detailed review of the patients files who underwent intracytoplasmic sperm injection (ICSI) trials starting January 2010 till January 2015 will be done.
Patients with diagnosed mullerian anomalies will have their name , age ,duration of infertility, serum FSH, LH ,\& AMH levels recorded. The method of diagnosis (HSG, 3D/ultrasonography, hysteroscopy, or laparoscopy) will also be documented.
- Conditions
- Infertility
- Being tested
- Anti Mullerian hormone level; Mullerian duct anomaly type
- Keywords
- anti-Müllerian hormone (AMH), Mullerian anomalies, ICSI
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti Mullerian hormone level; Mullerian duct anomaly typeOther
Diagnosis of Mullerian duct anomaly type Clinically or by Imaging Anti-Müllerian Hormone levels
| Study group | Role | What they receive |
|---|---|---|
| Mullerian duct anomalies | Anti Mullerian hormone level; Mullerian duct anomaly type Receives: Other: Anti Mullerian hormone level; Mullerian duct anomaly type |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of serum anti-Müllerian hormone (AMH) level with mullerian anomalies
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2015 (estimated)
- Study startApr 2015
- Primary completionNov 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InfertilityStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 226 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ahmed M.Kamel
- Sponsor type
- University, hospital or other
- Collaborators
- The Egyptian IVF-ET Center
- Responsible party
- Sponsor-investigator, Ahmed M.Kamel, Kasr El Aini Hospital
- Investigators
- Yahia El-fassial, M.D, Principal investigator, consultant
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02436538
- Sponsor's protocol ID
- 13546
- Status last verified
- Dec 2016
- First submitted
- 4 May 2015
- Last updated
- 6 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Li HW, Ng EH, Wong BP, Anderson RA, Ho PC, Yeung WS. Correlation between three assay systems for anti-Mullerian hormone (AMH) determination. J Assist Reprod Genet. 2012 Dec;29(12):1443-6. doi: 10.1007/s10815-012-9880-1. Epub 2012 Nov 2.
PubMed 23117477
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Serum Anti-Müllerian Hormone (AMH) Levels & Müllerian Ducts Anomalies in Patients Undergoingintracytoplasmic Sperm Injection (ICSI)
- ClinicalTrials.gov ID
- NCT02436538
- Acronym / sponsor ID
- 13546
- Conditions
- Infertility
- Keywords
- anti-Müllerian hormone (AMH), Mullerian anomalies, ICSI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 226 participants (actual)
- Lead sponsor
- Ahmed M.KamelUniversity, hospital or other
- Collaborators
- The Egyptian IVF-ET Center
- Study start
- Apr 2015
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 7 May 2015 (estimated)
- 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.
Anti-Müllerian hormone (AMH), also known as Müllerian inhibiting substance, is a dimeric glycoprotein that belongs to the transforming growth factor-beta family. It is involved in the regression of the Müllerian ducts during male fetal development. In the female, AMH is solely produced by the granulosa cells of preantral and small antral follicles, and regulates ovarian activity and follicular steroidogenesis
Detailed description
Following approval of the internal review board of Egyptian IVF-ET center, a retrospective analysis will be undertaken where a detailed review of the patients files who underwent intracytoplasmic sperm injection (ICSI) trials starting January 2010 till January 2015 will be done.
Patients with diagnosed mullerian anomalies will have their name , age ,duration of infertility, serum FSH, LH ,\& AMH levels recorded. The method of diagnosis (HSG, 3D/ultrasonography, hysteroscopy, or laparoscopy) will also be documented.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mullerian duct anomalies | – | Other: Anti Mullerian hormone level; Mullerian duct anomaly typeAnti Mullerian hormone level; Mullerian duct anomaly type |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- female undergoing intraCytoplasmic sperm injection for treatment of infertility
Key inclusion criteria (1 listed)
- women with diagnosed mullerian anomlies whether clinically or through imaging
Key exclusion criteria (3 listed)
- previous ovarian surgery
- ovarian drilling
- polycystic ovarian syndrome (PCOs).
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 |
|---|---|---|
| Anti Mullerian hormone level; Mullerian duct anomaly typeDiagnosis of Mullerian duct anomaly type Clinically or by Imaging Anti-Müllerian Hormone levels | Other | Mullerian duct anomalies |
Primary outcome
Correlation of serum anti-Müllerian hormone (AMH) level with mullerian anomalies
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2016.
- Background: PubMed 23117477Li HW, Ng EH, Wong BP, Anderson RA, Ho PC, Yeung WS. Correlation between three assay systems for anti-Mullerian hormone (AMH) determination. J Assist Reprod Genet. 2012 Dec;29(12):1443-6. doi: 10.1007/s10815-012-9880-1. Epub 2012 Nov 2.
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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.
Yahia El-fassial, M.D principal investigator
consultant
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, run by Ahmed M.Kamel at 1 site in Egypt.
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 1 inclusion and 3 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: finished, as of the sponsor's last update on 6 Dec 2016. 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 Egypt. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation of serum anti-Müllerian hormone (AMH) level with mullerian anomalies (time frame: 2 years). 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 NCT02436538, which also lists 1 linked publication.
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 Dec 2016.