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Serum Anti-mullerian Hormone and Polycystic Ovarian Syndrome

NCT03237312 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2017-08-02

No results posted yet for this study

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.

Conditions

  • Polycystic Ovary Syndrome

Interventions

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

1. In patients with Antimullerian hormone between 4-8 ng/ml 4 punctures in each ovary were performed. 2. In patients with Antimullerian hormone above 8 ng/ml 8 punctures in each ovary were performed.

Sponsors & Collaborators

  • Assiut University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
35 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-01
Primary Completion
2016-09-30
Completion
2016-11-30

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03237312 on ClinicalTrials.gov