GnRH Agonist Versus hCG Trigger in Ovulation Induction With Intrauterine Insemination.
Condition: Ovulation Induction
Study type: Interventional

Summary: 
      This study aims to compare clinical pregnancy rates (CPR) in patients who are administered
      either Gonadotropin-releasing hormone agonists (GnRHa) or human chorionic gonadotropin (hCG)
      for ovulation trigger in intrauterine insemination (IUI) cycles. A prospective randomized
      comparative study was conducted at Hue University Hospital in Vietnam. Total of 197 infertile
      women were randomly assigned to receive either GnRHa trigger (n=98 cycles) or hCG trigger (n=
      99 cycles) for ovulation trigger. Patients returned for ultrasound monitoring 24 hours after
      IUI to confirm ovulation. A clinical pregnancy was defined as the presence of gestational sac
      with fetal cardiac activity.
    

Detailed description: 
      Study design A prospective randomized comparative study was conducted at Hue University
      Hospital in Vietnam from April 2016 to June 2017 in 197 infertile women undergoing IUI. The
      study was approved by the Ethics Committee at Hue University of Medicine and Pharmacy.

      Study population A total of 217 women were recruited into the sample at the first stage.
      Inclusion criteria were women with bilateral tubal patency, at least one follicle ≥ 18mm in
      diameter on the day of trigger, and men with more than five millions total motile sperm after
      preparation. Only the first cycles of IUI were studied and there were 197 infertile women who
      obtained at least 1 mature follicle at the first cycle were included in analysis. Patients
      were randomly assigned to receive either GnRHa trigger (n=98 cycles) or hCG trigger (n= 99
      cycles) for ovulation trigger.

      Intervention All patients included in the study were subjected to complete history and
      physical. Patients with a history of abnormal menstrual cycles (amenorrhea, oligomenorrhea)
      underwent ovarian stimulation. Stimulation was started on cycle day eight with 75 IU Menogon
      (Ferring Pharm Co, Switzerland) daily. Ultrasound monitoring was required after every 2-3
      days of stimulation and adjustments to dose and duration were tailed according the patient's
      response. Ovulation was triggered when at least one and no more than 3 follicles reached
      ≥18mm in diameter. Patients were then randomly assigned to receive either two doses of GnRH-a
      (Fertipeptil 0.1mg x 2 vial; Ferring Pharm Co, Switzerland) or hCG (Pregnyl 5000IU; Organon
      Pharm Co, Nertheland) for ovulation trigger.

      IUI was then performed with sperm preparation by radiant centrifugation 36 hours after the
      trigger. Luteal phase support with progesterone 200mg daily (Utrogestan; Besins Health Care
      Com, Belgium) was started in the day of IUI.

      Assessment of outcomes Patients returned for ultrasound monitoring 24 hours after IUI to
      confirm ovulation which is determined by the accumulation of free fluid in peritoneum at
      Douglas sac and disappearance of the previous mature follicles.

      Serum β-human chorionic gonadotropin (βhCG) was collected 14 days after insemination. A
      biochemical pregnancy was defined by βhCG concentration > 25 mIU/ml (Shapphire 350; Cork Com,
      Ireland). Two weeks after a positive βhCG test, the patient returned for an ultrasound
      appointment. A clinical pregnancy was defined as the presence of gestational sac with fetal
      cardiac activity.
    

Intervention name(s): GnRHa (Fertipeptil 0.1mg); hCG (Pregnyl 5000IU)
Intervention type(s): Drug; Drug
Intervention description(s): Two doses of GnRH-a (Fertipeptil 0.1mg x 2 vial) for ovulation trigger after ovarian stimulation for IUI.; hCG (Pregnyl 5000IU) for ovulation trigger after ovarian stimulation for IUI.
Intervention MeSH terms: Chorionic Gonadotropin
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A prospective randomized comparative study was conducted at Hue University Hospital in Vietnam. Total of 197 infertile women were randomly assigned to receive either GnRHa trigger (n=98 cycles) or hCG trigger (n= 99 cycles) for ovulation trigger. Patients returned for ultrasound monitoring 24 hours after IUI to confirm ovulation.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: GnRH agonist trigger; hCG trigger; ovulation induction