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NCT02436538 Clinical Trial

Correlation Between Serum Anti-Müllerian Hormone & Müllerian Ducts Anomalies in Infertility

Infertility Clinical Trial

Official title:
Correlation Between Serum Anti-Müllerian Hormone (AMH) Levels & Müllerian Ducts Anomalies in Patients Undergoingintracytoplasmic Sperm Injection (ICSI)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02436538
Other study ID # 13546
Secondary ID
Status Completed
Phase N/A
First received May 4, 2015
Last updated December 3, 2016
Start date April 2015
Est. completion date November 2016

Study information
Verified date December 2016
Source Kasr El Aini Hospital
Contact n/a
Is FDA regulated No
Health authority Egypt: Institutional Review Board
Study type Observational

Clinical 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. In the female, AMH is solely produced by the granulosa cells of preantral and small antral follicles, and regulates ovarian activity and follicular steroidogenesis

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.

Recruitment information / eligibility
Status Completed
Enrollment 226
Est. completion date November 2016
Est. primary completion date November 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 20 Years to 40 Years
Eligibility Inclusion Criteria:

- women with diagnosed mullerian anomlies whether clinically or through imaging

Exclusion Criteria:

- previous ovarian surgery

- ovarian drilling

- polycystic ovarian syndrome (PCOs).

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

Intervention

Other:
• Anti Mullerian hormone level; Mullerian duct anomaly type
Diagnosis of Mullerian duct anomaly type Clinically or by Imaging Anti-Müllerian Hormone levels

Locations
Country Name City State
Egypt The Egyptian IVF-ET Center Cairo Maadi

Sponsors (2)
Lead Sponsor Collaborator
Ahmed M.Kamel The Egyptian IVF-ET Center

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

Li HW, Ng EH, Wong BP, Anderson RA, Ho PC, Yeung WS. Correlation between three assay systems for anti-Müllerian hormone (AMH) determination. J Assist Reprod Genet. 2012 Dec;29(12):1443-6. doi: 10.1007/s10815-012-9880-1. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Correlation of serum anti-Müllerian hormone (AMH) level with mullerian anomalies 2 years No
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