Early Luteal Hormones and IVF Outcomes After hCG Triggering
Condition: Luteal Phase; in Vitro Fertilisation
Study type: Observational

Summary: 
      It has recently been demonstrated that a bolus trigger of hCG induces various unphysiological
      conditions in the early luteal phase that may negatively affect an IVF treatment cycle's
      reproductive outcome. The bolus trigger of hCG differ from the natural cycle in mainly three
      different ways: 1) The timing of the initiation of hCG and progesterone rise is much faster
      after an hCG trigger than in the natural menstrual cycle 2) the maximal concentrations of hCG
      and progesterone considerably exceed those naturally observed 3) The timing of the peak
      progesterone concentration following an hCG trigger is advanced several days compared to the
      natural cycle. These characteristics may affect the reproductive outcome in treatment cycles
      but are not explored. The aim of this study is to monitor whether specific trajectories of
      important luteal phase hormones may predict the chances of conception?
    

Detailed description: 
      The early luteal phase after ovarian stimulation and final oocyte maturation using a bolus
      trigger of hCG is an area that has not received the same attention as regimes and protocols
      for ovarian stimulation during the follicular phase. The hCG trigger has been considered the
      golden standard since the beginning of the IVF era almost four decades ago. The hCG trigger
      serves two main functions: 1) it induces oocytes to advance meiosis to the metaphase of the
      second meiotic division ready for fertilization and further development, 2) secures
      stimulation of the corpora lutea to secrete progesterone (P4) during the early luteal phase
      due to its relatively long half-life. However, recent studies have suggested that each of
      these two functions may be optimized on their own and that better alternatives to the hCG
      trigger may be developed including a more physiological trigger for final maturation of
      follicles and individualized luteal phase support. However, only recently has the early
      luteal phase after IVF treatment using an hCG bolus trigger been described in studies
      involving more than just a few patients. These studies suggested that the unphysiological
      effects of the hCG trigger may be divided into three different categories: 1) The timing of
      the initiation of hCG and progesterone rise is much faster after an hCG trigger than in the
      natural menstrual cycle 2) the maximal concentrations of hCG and progesterone considerably
      exceed those naturally observed 3) The timing of the peak progesterone concentration
      following an hCG trigger is advanced several days compared to the natural cycle. How each of
      these effects influences pregnancy outcome in treatment cycles are currently unknown.
      Further, does characteristics shortly after administration of the hCG trigger for final
      oocyte maturation subsequently affect the reproductive outcome, and does this provide an
      opportunity for correcting or improving the luteal phase support given, with the improvement
      of clinical pregnancy rate as a result is also unknown. The aim of this study is to evaluate
      the trajectories of four hormones important for corpora lutea function (i.e. P4, 17-OH-P4,
      hCG, and inhibin-A) during the early luteal phase in women undergoing IVF treatment with
      luteal phase support given in the form of exogenous P4 administration and evaluate whether
      clinical pregnancy rates are related to specific characteristics of the early luteal phase.
      By including the measurements of 17-OH-P4 and inhibin-A the study will obtain an evaluation
      of the function of corpora lutea itself independent of the P4 administration provided.
    

Intervention name(s): Hormonal levels
Intervention type(s): Other
Intervention description(s): A total of ten (10) blood samples (2ml/each) will be collected during the study for subsequent analysis of progesterone, hCG, inhibin-A, and 17-OH-progesterone:
Day of triggering (before the injection of hCG, appx. 6 pm) Twelve (12 hours) after hCG injection (appx. at 6 am) Twenty-four (24) hours after hCG injection (appx. at 6 pm) Thirty-six (36) hours after hCG injection (appx. at 8 am, 2 hours after OPU) One (1) day after OPU (60h after hCG) (appx. at 6 am) Two (2) days after OPU (84h after hCG) (appx. at 6 am) Three (3) days after OPU 108h after hCG) (appx. at 6 am) Four (4) days after OPU (132h after hCG) (appx. at 6 am) Five (5) days after OPU (156h after hCG) (appx. at 6 am) Six (6) days after OPU (180h after hCG) (appx. at 6 am)
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Vietnamese women who will be indicated for IVF treatment with hCG administration for final
        oocytes maturation and undergo fresh embryo transfers.