Interest of Estrogen Scheduling Before Ovarian Stimulation With Corifollitropin Alfa
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 3

Summary: 
      E2 given in late luteal phase can be extended beyond the onset of menses for a period of at
      least eight days before the start of the stimulation, allowing scheduling of stimulation in
      order to limit oocytes retrievals during weekends .

      Administration of corifollitropin alfa, a Follicule stimulating Hormone (FSH) with extended
      release kinetics, seems particularly interesting for a synchronous recruitment of follicles
      after homogenization of the cohort.

      The objective of this study is to evaluate the impact on the response to ovarian stimulation
      with corifollitropin alfa of E2 scheduling versus no scheduling for women over 38 years, age
      at which declining of ovarian reserve usually begins. The management of these patients in
      terms of organization of the center is also evaluated.

      The scheduling of IVF cycles represents a double benefit. On one hand, to enable a
      "synchronization" of the follicular cohort for a best response and a higher number of mature
      oocytes. On the other hand, a more efficient organization for both the center (avoiding
      retrievals on weekends and public holidays, organize and distribute equally the activity,
      reduce cost operations) and couples (personal and professional organization).
    

Detailed description: 
      With advanced age, ovarian reserve decreases, follicular cohort becomes heterogeneous under
      the influence of higher FSH rise in late luteal phase. It has been shown that estrogens (E2)
      taken in the late luteal phase homogenized follicular cohort by inhibiting inter cycle FSH
      peak ,and that this inhibition is immediately reversible after discontinuation of treatment .

      E2 given in late luteal phase can also be extended beyond the onset of menses for a period of
      at least eight days before the start of the stimulation, allowing scheduling of stimulation
      in order to limit oocytes retrievals during weekends . A prospective randomized study
      comparing E2 scheduling and no scheduling has shown that there was no difference in birth
      rate in a population of normo-responders women . While in these patients, the number of
      oocytes was not different in the two arms, a recent pilot study founded a significant
      increase in the number of oocytes retrieved after E2 luteal phase priming compared to the
      absence of priming in a population of poor responders .

      In 2013, a report of the French governmental BioMedicine Agency warned about the
      thrombo-embolic risk associated with the use of the contraceptive pill for IVF scheduling,
      especially in women over 35.

      Administration of corifollitropin alfa, an FSH with extended release kinetics, seems
      particularly interesting for a synchronous recruitment of follicles after homogenization of
      the cohort. In the Pursue study, an equivalent efficacy has been shown with the daily
      administration of 300 IU FSH and corifollitropin alfa in patients over 35 years .

      The objective of this study is to evaluate the impact of the response to ovarian stimulation
      with corifollitropin alfa of E2 scheduling versus no scheduling for women over 38 years, age
      at which declining of ovarian reserve usually begins. The management of these patients in
      terms of organization of the center is also evaluated.

      The scheduling of IVF cycles represents a double benefit. On one hand, to enable a
      "synchronization" of the follicular cohort for a best response and a higher number of mature
      oocytes. On the other hand, a more efficient organization for both the center (avoiding
      retrievals on weekends and public holidays, organize and distribute equally the activity,
      reduce cost operations) and couples (personal and professional organization). This can be
      done with pills but there are controversial data on its impact on the chances of birth. It
      has been shown that estrogen scheduling provides opportunities for success equivalent to the
      absence of scheduling for patients with good prognosis . If this study confirms the initial
      hypothesis, it will show that a less favorable public can profit from the benefits of
      scheduling by estrogen on both the organization of the attempt and the chances of pregnancy
      through better ovarian response.
    

Intervention name(s): Estrogens
Intervention type(s): Drug
Intervention description(s): The estrogens pretreatment will began between the day 20 and the day 24 of an ovarian cycle and should be continued until Wednesday beyond the onset of menses
Intervention MeSH terms: Estrogens
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Fertility; Reproductive processes; In vitro fertilization; Intracytoplasmic sperm injection; Estrogens; Follicule Stimulating Hormon