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Laparoscopic Ovarian Diathermy or Metformin Plus Clomiphene Citrate Administration as Second-Line Treatment for Infertile Anovulatory Patients With Polycystic Ovary Syndrome: a Randomized Controlled Trial


Phase 4
18 Years
35 Years
Not Enrolling
Female
Polycystic Ovary Syndrome, Infertility, Anovulation

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Trial Information

Laparoscopic Ovarian Diathermy or Metformin Plus Clomiphene Citrate Administration as Second-Line Treatment for Infertile Anovulatory Patients With Polycystic Ovary Syndrome: a Randomized Controlled Trial


A total of 50 primary infertile anovulatory PCOS patients with documented CC-resistance will
be enrolled and randomized into two groups of treatment of 25 subjects each. Group A will
undergo diagnostic laparoscopy followed by metformin plus CC, whereas group B will undergo
LOD followed by observation. Anovulatory patients will receive IM progesterone. The
treatment will be of six months followed by nine-month of observation for pregnant patients.
The incidence of spontaneous menses, and the pregnancy, abortion, and live-birth rates will
be recorded.


Inclusion Criteria:



- PCOS

- Clomiphene citrate-resistance

- Anovulation

- Infertility

Exclusion Criteria:

- Age < 18 or > 35 years

- Body mass index >35

- Neoplastic, metabolic, endocrine, hepatic, renal, and cardiovascular disorders or
other concurrent medical illnesses

- Current or previous use of oral contraceptives, glucocorticoids, antiandrogens,
ovulation induction agents, antidiabetic and anti-obesity drugs or other drugs
affecting hormone levels, carbohydrate metabolism, or appetite

- Pelvic diseases

- Previous pelvic surgery

- Suspected peritoneal factor infertility/subfertility

- Tubal or male factor infertility or sub-fertility

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Live-birth rate

Outcome Time Frame:

fifteen months

Principal Investigator

Stefano Palomba, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Department of Obstetrics and Gynecology, University "Magna Graecia" of Catanzaro

Authority:

Italy: The Italian Medicines Agency

Study ID:

01/2003

NCT ID:

NCT00558077

Start Date:

February 2003

Completion Date:

October 2005

Related Keywords:

  • Polycystic Ovary Syndrome
  • Infertility
  • Anovulation
  • Anovulation
  • Clomiphene citrate
  • Fertility
  • Metformin
  • Ovulation induction
  • PCOS
  • Sterility
  • Treatment
  • Clomiphene citrate-resistance
  • Anovulation
  • Infertility
  • Polycystic Ovary Syndrome

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