Follicular Synchronization in PCOS Patients Undergoing ICSI
Condition: Polycystic Ovarian Syndrome
MeSH terms: Polycystic Ovary Syndrome; Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      The use of GnRH antagonist protocol nowadays is the slandered protocol of controlled ovarian
      stimulation in patients with poly cystic ovarian syndrome (PCOS) because it decreases the
      incidence of OHSS(1, 2). However, this protocol may lead to asynchronous growth of follicles
      with an early dominant follicle specially in PCOS patients(3). In most of cases this
      phenomenon will affect the IVF outcomes(2, 4) Aromatase inhibitors (AIs) nowadays is
      recommended to be used for ovulation induction in patients with PCOS (5, 6).It has fewer side
      effects, and a shorter half-life than clomiphene citrate(CC), and no effect ON the
      endometrial receptivity. It is used in treating patients with chronic anovulation,
      unexplained infertility and poor ovarian reserve(7). It acts through decreasing estrogen
      levels and allows follicle stimulating hormone (FSH) release from the hypothalamus (8, 9). It
      could be used alone or with combination with human menopausal gonadotropin (HMG) specially in
      patients with CC resistant(10-13). It also improves the ovarian response to FSH when they are
      used in combination and it decreases the risk of OHSS (14).

      This study aims to evaluate the effect of uses of letrozole in combination with HMG during
      ovarian stimulation in patients having PCOS undergoing IVF/ICSI on the follicular growth
      pattern, synchronized growth of follicles, maturity of oocyte and the quality of embryos.
    

Detailed description: 
      Participants in this study will be group of subfertile women undergoing IVF/ ICSI trial and
      having polycystic ovarian syndrome Inclusion criteria

        1. Ages ≥20 and <40 years old

        2. Women having the diagnosis of polycystic ovarian syndrome according to Rotterdam
           criteria (15)

        3. Women who have at least one of the following indications for IVF or ICSI:

             1. Resistance to slandered ovulation induction and life style modification

             2. Tubal factors: unilateral or bilateral tubal obstruction, unilateral or bilateral
                salpingectomy or tubal ligation

             3. Male factors: oligoasthenozoospermia or obstructive azoospermia Exclusion criteria

      1. Women with unexplained infertility. 2. women with poor ovarian reserve according to
      Bologna criteria (16). 3. Couples with known chromosomal abnormalities. 4. Women who refuse
      to participate in this study.

      Methods

        -  patients will be randomly assigned into two groups (100 patients in each group):
           letrozole group (study group) and non letrozole group (control group). Treatment
           assignment will be blinded to patients, physicians, and nursing staff.

        -  All patients will receive combined oral pills before stimulation.

        -  letrozole 2.5mg twice daily (Femara; Novartis Pharma Services, Basel, Switzerland) will
           be given for 5 days starting from the second day of menstruation in combination with low
           dose step up stimulation with recombinant FSH in the study group.

        -  Allocated patients will be randomized into either of two groups.
    

Intervention name(s): letrozole 2.5mg (Femara; Novartis Pharma Services, Basel, Switzerland)
Intervention type(s): Drug
Intervention description(s): letrozole /antagonist protocol
Other intervention name(s): letroz 2.5mg (Sun Pharmaceuticals Industries Ltd.,India)
Intervention MeSH terms: Letrozole
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: randomized controlled trial
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment