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Serum Anti-mullerian Hormone and Polycystic Ovarian Syndrome

A

Assiut University

Status and phase

Completed
Phase 2

Conditions

Polycystic Ovary Syndrome

Treatments

Procedure: Laparoscopic ovarian drilling
Biological: Antimullerian hormone

Study type

Interventional

Funder types

Other

Identifiers

NCT03237312
AMH-PCOS

Details and patient eligibility

About

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.

Enrollment

50 patients

Sex

Female

Ages

20 to 35 years old

Volunteers

No Healthy Volunteers

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 .

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

50 participants in 2 patient groups

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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