Serum Anti-mullerian Hormone and Polycystic Ovarian Syndrome

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

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.

Study Overview

• Status: Completed
• Conditions: Polycystic Ovary Syndrome
• Intervention / Treatment: Procedure: Laparoscopic ovarian drilling; Biological: Antimullerian hormone

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 2

Contacts and Locations

Study Locations

• Egypt
  • Assiut, Egypt, 71111
    • Women Health Hospital - Assiut university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 35 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 .

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: The control group; Four punctures in each ovary were done regardless of the level of antimullerian hormone	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.
OTHER: The study group; The number of ovarian drills was adjusted according to antimullerian hormone level	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Size of ovarian follicle (mm)	14 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Antimullerian hormone level (ng/dl)	3 months
Ovarian volume (ml)	3 months

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2015
• Primary Completion (ACTUAL): September 30, 2016
• Study Completion (ACTUAL): November 30, 2016

Study Registration Dates

• First Submitted: July 30, 2017
• First Submitted That Met QC Criteria: July 30, 2017
• First Posted (ACTUAL): August 2, 2017

Study Record Updates

• Last Update Posted (ACTUAL): August 2, 2017
• Last Update Submitted That Met QC Criteria: July 30, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Endocrine System Diseases; Disease; Ovarian Cysts; Cysts; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Polycystic Ovary Syndrome; Syndrome; Physiological Effects of Drugs; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormones
• Other Study ID Numbers: AMH-PCOS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No