Luteal Phase Support In IVF Women Using GnRH Agonist
Condition: IVF; Luteal Phase Defect
Study type: Observational

Summary: 
      Lately, the role of GnRH agonist as luteal phase support has been recommended by various
      studies though the mechanism is still debatable. It has been postulated that GnRH agonist
      might support the corpus luteum by stimulating the secretion of luteinizing hormone by
      pituitary gonadotroph cells, or by acting directly on the endometrium through the locally
      expressed receptors.

      Therefore, this study was designed to evaluate effects of the additional of single-dose GnRH
      agonist to the routine progestogens use for luteal phase support on IVF outcome as compared
      to progestogens only. The biochemical pregnancy rates, clinical pregnancy rates, live birth
      rates and miscarriage rate between these regimes were compared. The hypothesis of this study
      was women with addition of GnRH agonist as luteal phase support have higher biochemical
      pregnancy rate, clinical pregnancy rate and live birth rate compare to patient with
      progestogens only luteal phase support.
    

Detailed description: 
      This was a retrospective study on selected patients who underwent IVF treatment under MAC
      (Medically Assisted Conception) Unit, University Kebangsaan Malaysia Medical Centre for the
      period of June 2015-June 2018. Their medical records were reviewed, and data analysed.

      The sample size was calculated using Power & Sample Size Calculator by Dupont & Plummer 1998
      for dichotomous response version 3.1.2 [6]. Based on this formula, a is the type I error
      probability for a two-sided test allowable about 5% in this study. The power of certainty is
      the percentage of estimated power of this study. On the other hand, p0 is the probability of
      the outcome for GnRH agonist used as luteal phase support by Zafardoust et al. [7] which is
      30% (0.30). The p1 is the probability of the outcome in an experimental subject which
      expected in this study based on similar objective of higher rate of implantation with GnRH
      agonist. The investigators set the p1 is 0.50 as overall literature suggest that at
      cumulative successful of implantation post GnRH is around 30-50%. The m is the ratio of
      control to experimental subjects which is 1 to 1 in this study. Generated sample size from
      this program is 93 for one arm which result in total sample size is 186. The investigators
      then added 10% of additional sample for any bias or loss of data during follow up which
      concluded total sample size to be at least 200 samples (100 patients each arm).

      All women who underwent control-ovarian stimulation (COH) regime using either gonadotrophin
      combination with GnRH antagonist protocol or mild stimulation protocol using oral letrozole
      or clomiphene citrate were included in this study. All women underwent follicle tracking by
      transvaginal ultrasound until dominant follicle size reached (>18mm). IM Ovitrelle (6500 IU)
      was given and proceed with oocyte retrieval (OR) at least 35-36 hours under transvaginal
      ultrasonography guidance. The 17-gauge single -lumen needles used for oocyte retrieval under
      sedation.

      ICSI were performed according to local protocol. Zygotes were cultured up to day 5 in G1
      medium (Vitrolife). On day 5, embryos were graded according to previously described criteria.
      One or two embryos were transferred, depending on the morphological score and the
      developmental stage of the embryo, as well as the age of the patient.

      Regardless the ovarian stimulation protocols, these women were assigned into two group;
      progestogens with additions of GnRH agonist and progestogen only for luteal phase support.
      Both groups were given routine progestogen support for two weeks duration started from the
      day of embryo transfer. This includes oral progestogen (Tablet Duphaston 10mg tds), vaginal
      progestogen (vaginal utrogestan 400mg bd) or intramuscular (IM Proluton 250 mg weekly) as
      prescribed by attending clinician .

      In the first group, there were additional GnRH agonist administrated as a single dose of 0.2
      mg decapeptyl given at day 3 after ICSI. The other group with no GnRH agonist given was the
      control group.
    

Intervention name(s): Decapeptyl 0.2mg
Intervention type(s): Drug
Intervention description(s): IM Decapeptyl o.2 mg was given 2 days before embryo transfer
Intervention MeSH terms: Triptorelin Pamoate
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Data women underwent IVF treatment under MAC (Medically Assisted Conception) Unit,
        University Kebangsaan Malaysia Medical Centre for the period of June 2015-June 2018 were
        reviewed.
      
Keywords: Luteal phase support; GnRH agonist; in vitro fertilization