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Letrozole Combined With Gn for Ovarian Hyperstimulation Undergoing IVF/ICSI in Patients With PCOS

Open (Enrolling by invite only)
Polycystic Ovarian Syndrome

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Trial Information

Letrozole Combined With Gn for Ovarian Hyperstimulation Undergoing IVF/ICSI in Patients With PCOS

Polycystic ovarian syndrome (PCOS) occurs in 4% to 7% of all women of reproductive age and
20% of women presenting with anovulatory infertility. A significant proportion of these
women will ultimately need assisted reproductive techniques. Various protocols of ovarian
stimulation such as step up protocol, coasting, GnRH antagonists et al have been proposed
for optimizing IVF results in patients with PCOS. The results of these studies have shown it
not to be satisfied. The preliminary studies have proven that Letrozole, a potent and highly
specific nonsteroidal aromatase inhibitor, could successfully induce ovulation in women with
polycystic ovary syndrome. In spite of only a little study research of letrozole in IVF/ICSI
cycle, for poor ovarian responders, addition of letrozole improved ovarian response to FSH
and reduced gonadotrophin dose required for COH without having a negative impact on
pregnancy rates. These reports prompted us to hypothesize that adjunctive use of letrozole
in COH protocol for patients with PCOS would minimize the gonadotrophin dose, and
consequently the cost, and lower the risk of OHSS in a IVF/ICSI treatment cycle.

Inclusion Criteria:

- patients with PCOS

Type of Study:


Study Design:

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

Outcome Measure:

Cycle cancellation rate, number of oocytes retrieved, fertilization rate, embryo quality, clinical pregnancy, implantation rates and OHSS rate

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

zhang changjun, doctor

Investigator Role:

Study Director

Investigator Affiliation:

renmin hospital,yunyang medical college


China: Ministry of Health

Study ID:




Start Date:

January 2008

Completion Date:

December 2009

Related Keywords:

  • Polycystic Ovarian Syndrome
  • letrozole
  • ovarian stimulation
  • PCOS
  • IVF-ET
  • Polycystic Ovary Syndrome