Dual FSH/HCG Trigger in Letrozole Stimulated Intrauterine Insemination Cycles in Women With Unexplained Infertility
Condition: Unexplained Infertility
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of this study was to evaluate the outcome of follicle stimulating hormone (FSH)
      co-administration with human chorionic gonadotrophins trigger for women with unexplained
      infertility (UEI) and assigned for letrozole (LTZ) stimulated intrauterine insemination (IUI)
      cycles .
    

Detailed description: 
      This prospective randomized controlled study included 108 women with unexplained infertility
      recruited among those attending the Gynecology Outpatient Clinics of, Benha University
      Hospital, and private settings, Alkalubia, Egypt from Jun 2013 to Aug 2015. The study
      protocol was approved by the Local Ethics Committee and written informed consents were taken
      from both partners before starting of the study.

      All women received the same regimen of ovarian stimulation using Letrozole (Femara; Novartis
      pharma AG, Basle, Switzerland) 2.5 mg tab twice daily for 5 days starting from cycle day 3.
      Transvaginal ultrasound scan (TVS) was performed daily from cycle day 9 and a total of 10,000
      IU of hCG (Epifasi, EPICO) was administered to those in whom at least one ovarian follicle
      was ≥18 mm in size. On the day of hCG administration women were randomly categorized into two
      groups according to a computer generated random numerical table. Envelopes containing the
      allocation information were chosen sequentially by patient herself in presence of her
      husband. Group A received FSH (urofollitropin; Fostimon, IBSA, Bazel, Swiz; 75 IU amp) 150 IU
      injected once on day of hCG injection and group B received no FSH on day of hCG injection.
      Intrauterine insemination was performed 36 hours after HCG injection. Women in both groups
      received luteal phase support in the form of vaginal progesterone, (Prontogest 400 mg Vaginal
      Pessaries, IBSA) twice a day, starting from the day after IUI and continued till the eighth
      week, if the pregnancy test was positive.Two weeks later, quantitative ßhCG was estimated to
      diagnose chemical pregnancy. However, TVS was performed 4 weeks after positive pregnancy test
      to confirm clinical pregnancy by the presence of gestational sac with fetal echoes and
      pulsation and to exclude ectopic pregnancy. All women enrolled in the study underwent the
      study protocol for three consecutive cycles unless got pregnant.
    

Intervention name(s): Human chorionic gonadotropin; FSH co-trigger; Letrozole
Intervention type(s): Drug; Drug; Drug
Intervention description(s): In letrozole stimulated cycle; Human chorionic gonadotropin ( hCG) 10000 IU was given intramuscular when the mean ovarian follicle diameter was ≥18 mm.; In letrozole stimulated cycle; FSH (urofollitropin; Fostimon, IBSA, Bazel, Swiz; 75 IU amp) 150 IU injected once intramuscular when the mean ovarian follicle diameter was ≥18 mm.; Letrozole oral tablets (Femara 2.5 mg tablet; Novartis Pharma Services, Switzerland) 2.5 mg tab twice daily for 5 days from cycle day 3.
Intervention MeSH terms: Letrozole; Chorionic Gonadotropin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment