Natural Cycle Versus Stimulated Cycle Before Frozen Embryo Transfer
Condition: Fertility
Study type: Interventional
Phase: Phase 4

Summary: 
      Embryo freezing is a technique used regularly to optimize the pregnancy rate in case of
      infertility. This method is performed in presence of supernumerary embryo(s) after fresh
      transfer, or after freeze all embryos in case of medical reasons. It is necessary to control
      that the transfer is performed when the endometrium is receptive, which is essential for
      embryo implantation and pregnancy. This period is defined as the "implantation window".
      Endometrial preparation can be achieved by hormone replacement therapy (HRT) or moderate
      ovarian stimulation (SO). The implantation window can also be assessed by monitoring of a
      natural cycle (NC). The objectives of this open randomized study is to compare the number of
      visits (ultrasound and blood tests) induced by the SO or NC as well as the women quality of
      life in both groups.
    

Detailed description: 
      For infertile couples supported by in vitro fertilization, embryo freezing is a technique
      used regularly to optimize the pregnancy rate per retrieval of oocytes. This method is
      performed in case of supernumerary embryo(s) after fresh embryo transfer, or freeze all of
      the embryonic cohort in case of medical reasons preventing the transfer. The embryo or
      embryos can then be thawed and transferred (FET) to achieve a live birth. However, it is
      necessary to first ensure that the transfer is carried out at a time when the endometrium is
      receptive, which is essential for embryo implantation and pregnancy. This period is defined
      as the "implantation window". Endometrial preparation can be performed by hormone replacement
      therapy (HRT) or moderate ovarian stimulation (SO). The implantation window can also be
      assessed by the monitoring of a natural cycle (NC). The choice of the key moment for the
      transfer is determined by ovulation and / or the rise of progesterone. To date, no study has
      demonstrated the superiority of one protocol over another in terms of birth rates. In the
      investigative center, treatment is usually carried out by daily subcutaneous injections of
      gonadotrophins followed by ovulation induction. In this context, the implementation of the
      FET in natural cycle may appear less burdensome for the patient and more physiological. The
      consideration is additional constraints, NC imposing more frequent monitoring (ultrasound and
      / or hormone assays) to detect the ovulation peak and less freedom in choosing the date of
      transfer. The average number of visits with SO is 2.6 per cycle. The aim of this study is to
      compare the stresses and safety of these two therapeutic proposals to determine the least
      restrictive for patients.
    

Intervention name(s): natural cycle; moderate ovarian stimulation
Intervention type(s): Other; Drug
Intervention description(s): Ovulation is not induced by drugs; Ovulation is induced by recombinant follitropin alpha and recombinant choriogonadotropin
Other intervention name(s): natural; ovarian stimulation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Ovulation Induction; quality of life; Reproductive Physiological Processes; fertility