Single Injection of Ganirelix in Gonadotropin Intrauterine Insemination (IUI) Cycles
Condition: Compare Pregnancy Rates Between FSH Stimulation and FSH and; GnRH Antagonist
Study type: Interventional

Summary: 
      Ovulation induction (OI) using gonadotropins is one of the most widely prescribed treatments
      of infertility. One common problem encountered while attempting OI using gonadotropins is
      premature ovulation. The purpose of this study is to examine the effect of a single injection
      of a medication, called ganirelix, to prevent premature ovulation. Patients will be divided
      into two groups. In the first group, gonadotropins will be used to stimulate the ovaries. In
      the second group gonadotropins will be used in addition to a single injection of ganirelix, a
      gonadotropin releasing hormone (GnRH) antagonist. Pregnancy rates will be compared between
      groups.
    

Detailed description: 
      A randomized prospective study will be performed on patients attempting pregnancy using
      ovulation induction/intra-uterine insemination (IUI). Patients will be randomly assigned to
      one of two protocols:

      Protocol A (control group): On menstrual cycle day 3, the patient will start gonadotropins
      (Follistim) injections at a starting dose of 75-150 IU and monitored according to the
      discretion of the treating physician. When the leading follicle reaches a size of at least
      18mm, intramuscular human chorionic gonadotripin (hCG) (10,000 IU) is administered, followed
      by two inseminations, one at 12 hours after hCG, and the other at 36 hours. All patients will
      have luteal support using progesterone vaginal suppositories at a dose of 200mg two times per
      day (BID). Pregnancy testing will be scheduled at 2 weeks after the IUI. The treatment cycle
      typically lasts from 8-13 days, depending on the patient's response.

      Protocol B (study group): On menstrual cycle day 3, the patient will start gonadotropins
      (Follistim) injections at a starting dose of 75-150 IU and monitored according to the
      discretion of the treating physician. When the leading follicle reaches a size of 13-14mm in
      mean diameter, or when the estradiol level reaches a level of 400 pg/ml, ganirelix injection
      at the standard dose of 250mcg is given once subcutaneously. When the leading follicle
      reaches a size of at least 18mm, intramuscular hCG (10,000IU) is administered followed by two
      inseminations, one at 12 hours after hCG, and the other at 36 hours. All patients will have
      luteal support using progesterone suppositories at a dose of 200mg BID. Pregnancy testing
      will be scheduled at 2 weeks after the IUI. The treatment cycle typically lasts from 8-13
      days, depending on the patient's response.

      Patients will be randomized, via computer generated program, in a 1:1 fashion.
    

Intervention name(s): Follistim administration; Follistim plus Ganirelix
Intervention type(s): Drug; Drug
Intervention description(s): adminstation of FSH for ovulation induction; Follistim plus single injection of ganirelix
Other intervention name(s): Follistim; Follistim; ganirelix
Intervention MeSH terms: Ganirelix
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ovulation induction, GnRH