Serum Anti-mullerian Hormone and Polycystic Ovarian Syndrome

Phase 2

Completed

• Conditions: Polycystic Ovary Syndrome
• Interventions: Procedure: Laparoscopic ovarian drilling; Biological: Antimullerian hormone

• Registration Number: NCT03237312
• Lead Sponsor: Assiut University

Brief Summary

In 1935 the polycystic ovary syndrome was a clinical diagnosis made on the morphological appearance of the ovaries in association with amenorrhoea, hirsutism and frequently obesity. At that time wedge resection of the ovaries was introduced on an empirical basis and proved a successful treatment for the associated anovulation and infertility. In the ensuing fifty years the limitations of a purely surgical approach to therapy have become recognized and the importance of the biochemical abnormalities appreciated. Prevalence of polycystic Ovary Syndrome: The prevalence of polycystic ovary syndrome in any specified population is dependent upon the diagnostic criteria used, but does have some regional and ethnic variation. While most reports on the prevalence of polycystic ovary syndrome range between 2 and 20%, the chosen diagnostic criteria are recognized to influence the determined prevalence. Anti-mullerian hormone which is a predictor of ovarian reserve is known to decrease after laparoscopic ovarian drilling. On the best of our knowledge no study had been done to use the level of anti-mullerian hormone as a factor for planning the number of ovarian drills in each ovary.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2015-01-01
• Primary Completion: 2016-09-30
• Study Completion: 2016-11-30
• Status Verified: 2017-07
• Study First Submitted: 2017-07-30
• Study First Submitted QC: 2017-07-30
• Last Update Submitted: 2017-07-30
• Study First Posted: 2017-08-02
• Last Update Posted: 2017-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 50

Inclusion Criteria

1. Infertility more than 2 years.
2. Age between 20-35 years.
3. clomiphene resistant patients: Patients received clomiphene 150 mg from day 3 to 7 of the menstrual cycle for 6 months and non-ovulatory (with failure of conception). They were followed up in the outpatient clinic.
4. No contraindications for laparoscopy.
5. Normal Hysterosalpingography

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Exclusion Criteria

1. Contraindications for laparoscopy e.g cardiac diseases, bad scared abdomen ect....
2. Women's age less than 20 years or more than 35 years.
3. Previous Laparoscopic surgery.
4. Previous ovarian surgery.
5. Women with Antimullerian hormone level less than 4 ng/ml.
6. Tubal factor infertility as diagnosed by Hysterosalpingography .

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
The study group	Antimullerian hormone	The number of ovarian drills was adjusted according to antimullerian hormone level
The study group	Laparoscopic ovarian drilling	The number of ovarian drills was adjusted according to antimullerian hormone level
The control group	Laparoscopic ovarian drilling	Four punctures in each ovary were done regardless of the level of antimullerian hormone
The control group	Antimullerian hormone	Four punctures in each ovary were done regardless of the level of antimullerian hormone

Primary Outcome Measures

Name	Time	Method
Size of ovarian follicle (mm)	14 days

Secondary Outcome Measures

Name	Time	Method
Antimullerian hormone level (ng/dl)	3 months
Ovarian volume (ml)	3 months

Trial Locations

Locations (1)

Women Health Hospital - Assiut university; 🇪🇬 Assiut, Egypt