Serum Anti-mullerian Hormone and Polycystic Ovarian Syndrome
Primary Purpose
Polycystic Ovary Syndrome
Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Laparoscopic ovarian drilling
Antimullerian hormone
Sponsored by
About this trial
This is an interventional treatment trial for Polycystic Ovary Syndrome
Eligibility Criteria
Inclusion Criteria:
- Infertility more than 2 years.
- Age between 20-35 years.
- 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.
- No contraindications for laparoscopy.
- Normal Hysterosalpingography
Exclusion Criteria:
- Contraindications for laparoscopy e.g cardiac diseases, bad scared abdomen ect….
- Women's age less than 20 years or more than 35 years.
- Previous Laparoscopic surgery.
- Previous ovarian surgery.
- Women with Antimullerian hormone level less than 4 ng/ml.
- Tubal factor infertility as diagnosed by Hysterosalpingography .
Sites / Locations
- Women Health Hospital - Assiut university
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
The control group
The study group
Arm Description
Four punctures in each ovary were done regardless of the level of antimullerian hormone
The number of ovarian drills was adjusted according to antimullerian hormone level
Outcomes
Primary Outcome Measures
Size of ovarian follicle (mm)
Secondary Outcome Measures
Antimullerian hormone level (ng/dl)
Ovarian volume (ml)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03237312
Brief Title
Serum Anti-mullerian Hormone and Polycystic Ovarian Syndrome
Official Title
The Impact of Serum Antimullerian Hormone Level on Adjusting the Number of Ovarian Drills in Polycystic Ovarian Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
January 1, 2015 (Actual)
Primary Completion Date
September 30, 2016 (Actual)
Study Completion Date
November 30, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Ovary Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
The control group
Arm Type
Other
Arm Description
Four punctures in each ovary were done regardless of the level of antimullerian hormone
Arm Title
The study group
Arm Type
Other
Arm Description
The number of ovarian drills was adjusted according to antimullerian hormone level
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic ovarian drilling
Intervention Description
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.
Intervention Type
Biological
Intervention Name(s)
Antimullerian hormone
Intervention Description
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.
Primary Outcome Measure Information:
Title
Size of ovarian follicle (mm)
Time Frame
14 days
Secondary Outcome Measure Information:
Title
Antimullerian hormone level (ng/dl)
Time Frame
3 months
Title
Ovarian volume (ml)
Time Frame
3 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Infertility more than 2 years.
Age between 20-35 years.
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.
No contraindications for laparoscopy.
Normal Hysterosalpingography
Exclusion Criteria:
Contraindications for laparoscopy e.g cardiac diseases, bad scared abdomen ect….
Women's age less than 20 years or more than 35 years.
Previous Laparoscopic surgery.
Previous ovarian surgery.
Women with Antimullerian hormone level less than 4 ng/ml.
Tubal factor infertility as diagnosed by Hysterosalpingography .
Facility Information:
Facility Name
Women Health Hospital - Assiut university
City
Assiut
ZIP/Postal Code
71111
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Serum Anti-mullerian Hormone and Polycystic Ovarian Syndrome
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