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Completed

NCT Number: NCT03237312

Serum Anti-mullerian Hormone and 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.

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Key information

Age range

20 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Women Health Hospital - Assiut university

Asyut, 71111, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 .

Treatment and study plan

Laparoscopic ovarian drilling

Procedure

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.

Antimullerian hormone

Biological
  • 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 outcomes

  1. Size of ovarian follicle (mm)

    Time frame: 14 days

Secondary outcomes

  1. Antimullerian hormone level (ng/dl)

    Time frame: 3 months

  2. Ovarian volume (ml)

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Aug 2, 2017
Registry last updated
Aug 2, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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