Serum Anti-mullerian Hormone and Polycystic Ovarian Syndrome

Polycystic Ovary Syndrome Clinical Trial

Official title:

The Impact of Serum Antimullerian Hormone Level on Adjusting the Number of Ovarian Drills in Polycystic Ovarian Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03237312
• Other study ID #: AMH-PCOS
• Status: Completed
• Phase: Phase 2
• First received: July 30, 2017
• Last updated: July 30, 2017
• Start date: January 1, 2015
• Est. completion date: November 30, 2016

Study information

• Verified date: July 2017
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: November 30, 2016
• Est. primary completion date: September 30, 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 35 Years

Eligibility

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

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 .

Related Conditions & MeSH terms

• Polycystic Ovary Syndrome
• Syndrome

Intervention

Procedure:
• Laparoscopic ovarian drilling
The electric current used was set at 40 Watts. The power was activated just before touching the ovary, and then the needle electrode was held against the antimesenteric surface of the ovary for 4 seconds until penetration of the ovarian capsule. Four or eight puncture points were made through the ovarian capsule of each ovary according to the study protocol. The ovaries were cooled in the pool of the Ringer's lactate after each cauterization both to minimize adhesion formation and to prevent heat trauma to the adjacent viscera. Complete hemostasis was ensured. At the end of the procedure, the ovaries were copiously rinsed with Ringer's lactate (Aqua-purator, Storz, Germany). An amount about 200 ml of heparinized Ringers lactate (5000 IU/1000 ml) was left in the pelvis to avoid postoperative adhesions.

Biological:
• Antimullerian hormone
In patients with Antimullerian hormone between 4-8 ng/ml 4 punctures in each ovary were performed. In patients with Antimullerian hormone above 8 ng/ml 8 punctures in each ovary were performed.

Locations

Country	Name	City	State
Egypt	Women Health Hospital - Assiut university	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Size of ovarian follicle (mm)		14 days
Secondary	Antimullerian hormone level (ng/dl)		3 months
Secondary	Ovarian volume (ml)		3 months