Efficacy of Pergoveris in Aged IVF Patients
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional

Summary: 
      To compare the efficacy between LH supplementation (Pergoveris) and non-LH supplementation
      (Follitropin alpha) in patients aged ≥ 35 years undergoing IVF treatment.

      Study hypothesis: Pergoveris (LH supplementation) is better than follitropin alpha (non-LH
      supplementation) for ovarian stimulation in aged IVF patients.
    

Detailed description: 
      A randomized controlled single center study.

      Based on the difference of 19.1% in the clinical pregnancy rate between the two treatment
      groups, with and without LH supplementation, in a previous study, with 90% power and a
      2-sided P-value of 0.05, the number of subjects required was 109 per group (total 218). The
      recruitment target was 120 subjects per group (total 240) to allow for dropouts.

      Eligible subjects were randomized in blocks of 4 via a computer generated random number list
      to either the Pergoveris arm or the follitropin alpha arm.

      Ovarian stimulation was performed by using GnRH antagonist protocol.

      Follitropin alfa (recombinant FSH) was administered on day 2 or day 3 of the menstrual cycle.
      The first FSH dose was determined according to each individual patient, based on the process
      as follows:

        -  AFC ≤ 6: 300 IU/day

        -  AFC 7-15: 225 IU/day

        -  AFC ≥ 16: 150 IU/day

      GnRH antagonist (Cetrotide, Merck-Serono) was administered on day 5 of FSH administration.

        -  Recombinant LH (in the form of Pergoveris) was supplemented from day 6 of FSH
           administration. Patients in the Pergoveris group would be administered a reduced dose of
           recombinant FSH (reduced by 150 IU/day) which was replaced with Pergoveris (150IU FSH +
           75IU LH)/day.

        -  The Follitropin alpha group retained recombinant FSH. In both groups, if the number of
           developing follicles was inappropriate, the dose could be titrated depending on the
           physician's judgment.

      Monitoring the follicular development was performed by vaginal ultrasound probe, quantifying
      LH, estradiol and progesterone, starting from day 5 of FSH, based on the current processes of
      the hospital.

      OPU and embryo transfer: OPU was performed 36 hours after hCG administration. Embryos were
      transferred on day 2.

      Luteal phase support: daily vaginal progesterone

      Pregnancy testing and ultrasound: a pregnancy test was done 14 days after embryo transfer.
      Beta hCG > 5mIU/ml was considered positive. Fetal ultrasound was performed 3 weeks after a
      positive pregnancy test to verify clinical pregnancy.
    

Intervention name(s): Pergoveris (FSH and LH); Follitropin alpha (FSH)
Intervention type(s): Drug; Drug
Intervention description(s): Drugs are injected subcutaneously everyday until ovarian follicles reach 17mm in diameter.; Drugs are injected subcutaneously everyday until ovarian follicles reach 17mm in diameter.
Other intervention name(s): Pergoveris; Gonal-F
Intervention MeSH terms: Follicle Stimulating Hormone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: IVF; LH supplementation; ovarian stimulation; poor responder