Ovarian Stimulation With Recombinant Gonadotropins vs. Human Menopausal Gonadotropin in In Vitro Fertilization
Condition: Infertility
MeSH terms: Infertility
Study type: Observational

Summary: 
      The purpose of this retrospective study was to assess the outcome of In Vitro Fertilization
      (IVF) according to the type of medication used for controlled ovarian stimulation (COS). The
      study compared the pregnancy rate obtained by 398 patients who had received COS with
      recombinant Follicle Stimulating Hormone (rFSH) plus recombinant Luteinising Hormone (rLH) in
      2:1 ratio vs. the one observed in 450 patients who had been treated with human Menopausal
      Gonadotropin (hMG), stratifying results according to the number of retrieved oocytes.
    

Detailed description: 
      Data were retrospectively collected from the clinical charts of our In Vitro Fertilization
      (IVF) Unit database. Among 3,416 cases recorded in the database, patients classified as
      expected poor responders and/or expected normal responders, requiring an average daily
      gonadotropin dose of 150-300 IU, were selected. A total of 848 patients matched this
      criterion and were included in the final analysis; of these, 398 (Group A) had been
      stimulated with rFSH+rLH, whereas 450 (Group B) had been treated with hMG.

      Patients in Group A (n=398) had been stimulated either with a starting dose of 150-300
      International Units per day (IU/d) recombinant Follicle Stimulating Hormone (rFSH) plus
      75-150 IU/d recombinant Luteinising Hormone (rLH) in 2:1 ratio. On day 6-7 of ovarian
      stimulation, the gonadotropin dose had been adapted according to the ovarian response, always
      maintaining the same rFSH:rLH ratio.

      Patients in Group B (n=450) had received 150-300 IU/d human Menopausal Gonadotropin,
      eventually adjusting the dose on day 6-7 of ovarian stimulation.

      Either medication had been administered within a "long" protocol with Gonadotropin-releasing
      Hormone (GnRH)-agonist or a "short" protocol with GnRH-antagonist. The COS regimen (type of
      protocol and type of medication) had been prescribed in the absence of any pre-fixed criteria
      at the time of prescription by different physicians of the Unit, basing the choice of
      appropriate dosages on the clinical experience, considering parameters such as age, small
      antrall follicle count and basal day 3 FSH.

      The classical "long" protocol had been performed administering the GnRH-agonist buserelin
      (900 mcg/d intranasally) from day 21 of the preceding cycle. In the "short" protocol, the
      GnRH-antagonist cetrorelix had been started at a subcutaneous dose of 0.25 mg/d according to
      a flexible schedule, when at least one follicle ≥14 mm diameter was observed at ultrasound
      (US).

      COS had been monitored by transvaginal US plus serum estradiol (E2) measurement performed
      every second day from stimulation day 6-7. From stimulation day 6-7 onward, checkpoints had
      been performed until at least one dominant follicle had reached 18 mm diameter, with
      appropriate E2 levels. At this point, ovulation had been triggered by injecting
      subcutaneously 10,000 IU of human Chorionic Gonadotropin, and transvaginal US-guided oocyte
      aspiration (OPU) had been performed approximately 36-37 hours after hCG injection under local
      anesthesia (paracervical block).

      Classical IVF or ICSI had followed, according to the clinical indication. After two days of
      in vitro culture, embryos had been scored and 1-3 of them had been transferred in uteri using
      a soft catheter under US guidance.

      The luteal phase had been supported administering 180 mg/d natural progesterone for 15 days.
      Pregnancy had been assessed by serum hCG assay after 15 days from embryo transfer and then
      confirmed if at least one gestational sac was visualized at transvaginal US after two further
      weeks.
    

Intervention name(s): rFSH plus rLH; hMG
Intervention type(s): Drug; Drug
Intervention description(s): 150-300 IU/d rFSH plus 75-150 IU/d rLH in 2:1 ratio; 150-300 IU/d hMG
Other intervention name(s): Gonal F, Luveris, Pergoveris; Meropur
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Infertile women requiring IVF and classified as expected poor responders and/or expected
        normal responders on the basis of age, basal FSH circulating levels, anti-mullerian Hormone
        (AMH) circulating level and basal antral follicle count.