Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03803228 |
| Other study ID # |
BISTIM |
| Secondary ID |
|
| Status |
Completed |
| Phase |
Phase 3
|
| First received |
|
| Last updated |
|
| Start date |
September 3, 2018 |
| Est. completion date |
November 24, 2021 |
Study information
| Verified date |
December 2022 |
| Source |
Centre Hospitalier Intercommunal Creteil |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
During ovarian stimulation, all the follicles grow under the action of FSH, only the selected
follicles and with the faster growth are taken. However during this stimulation, other
smaller follicles are also recruited and sensitized, which may increase the selection of
follicles available on the follicular wave following. In patients with weak reserve this
potentiation has a great interest, and the sequence of 2 stimulations on the same cycle could
make it possible to obtain a larger number of oocytes and embryos, thus giving a better
chance of delivery than on 2 distinct cycles of stimulation. However, this is preliminary
data that needs to be confirmed with a randomized controlled trial. In this population of
poor prognosis, the use of FSH-associated LH activity may optimize the ovarian response to
stimulation, particularly the combination containing placental HCG (Fertistartkit®) that
obtaining a slightly higher number of oocytes than highly purified HMG (Menopur®).
Description:
Ovarian stimulation is an essential prerequisite for any in vitro fertilization attempt (IVF)
to optimize the chances of delivery per cycle. These depend in the first place on the age of
the patients and secondly on the number of oocytes collected. There is a strong correlation
between these two factors, the ovarian reserve diminishing with age. In older patients or
patients with decreased reserve, however, the number of oocytes collected remains a
prognostic factor for the chances of delivery.
At the present time, there is no validated intervention that would bring a significant
interest on the number of oocytes obtained in the group of bad responder patients. However,
it is a very heterogeneous population whose definition has been proposed only recently, the
Bologna criteria and questioned by a new proposal from the Poseidon group. The latter is more
focused on the prognosis of success, differentiating patients with a diminished reserve
(count of antral follicles CFA <5 and / or AMH <1.2 ng / ml) from those with an "unexpected"
bad response. As the profiles are better defined, it is easier to determine the impact of a
strategy in a specific group.
Recent clarifications on the ovarian cycle and folliculogenesis have shown that several waves
of follicular development coexist on the same cycle and that it is perfectly possible to
obtain a follicular development with a luteal phase equivalent oocyte quality, compared to
conventional stimulations performed in the follicular phase. The main constraint of luteal
phase stimulation is the lack of possibility of fresh transfer due to non-synchronization
with the endometrium. This constraint is today secondary given the evolution of conservation
techniques with the development of embryonic and oocyte vitrification.
On the other hand, there is a differential dependence of FSH follicles, their sensitivity
depending on the number of FSH receptors and their duration of exposure to FSH. During
ovarian stimulation, all the follicles grow under the action of FSH, only the selected
follicles and with the faster growth are taken. However during this stimulation, other
smaller follicles are also recruited and sensitized, which may increase the selection of
follicles available on the follicular wave following. In patients with weak reserve this
potentiation has a great interest, and the sequence of 2 stimulations on the same cycle could
make it possible to obtain a larger number of oocytes and embryos, thus giving a better
chance of delivery than on 2 distinct cycles of stimulation. However, this is preliminary
data that needs to be confirmed with a randomized controlled trial. In this population of
poor prognosis, the use of FSH-associated LH activity may optimize the ovarian response to
stimulation, particularly the combination containing placental HCG (Fertistartkit®) that
obtaining a slightly higher number of oocytes than highly purified HMG (Menopur®).
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