Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT06106919 |
| Other study ID # |
Local/2023/SH-01 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
December 18, 2023 |
| Est. completion date |
December 31, 2025 |
Study information
| Verified date |
February 2024 |
| Source |
Centre Hospitalier Universitaire de Nimes |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial Summary
The aim of the study is to demonstrate the non-inferiority of dienogest on the number of
mature oocytes collected compared with "conventional" ovarian stimulation protocols (using a
GnRH agonist or antagonist), in patients with endometriosis in a fertility preservation
context.
Description:
Endometriosis is a common pathology affecting 1 in 10 women of childbearing age, and is
responsible for around 40% of infertility cases.
The impact of endometriosis on fertility has now been clearly demonstrated, making it a
medical indication for fertility preservation.
Today, dienogest is a key element in the therapeutic arsenal, helping to alleviate painful
symptoms, reduce endometriosis lesions and improve patients' quality of life.
By creating a hypo-oestrogenic and hyperprogestogenic climate, dienogest at a daily dose of
2mg not only atrophies the endometrial tissue of endometriotic lesions, but also inhibits
ovulation, enabling it to be used as an adjuvant treatment to ovarian stimulation.
There are currently 3 protocols commonly used during ovarian stimulation for oocyte
self-preservation: the antagonist protocol (using a GnRH antagonist), the agonist protocol
(using a GnRH agonist) and the PPOS protocol (using a progestin, which may be dienogest). In
patients undergoing long-term dienogest therapy, the first 2 protocols require
discontinuation of background treatment, which entails a risk of recurrence of symptoms and
progression of endometriosis lesions, unlike the PPOS protocol, which allows dienogest
treatment to be continued during stimulation.
A few studies have looked at progestin blockade of ovulation during ovarian stimulation and
found no negative impact on the number of oocytes collected, compared with commonly used
protocols (antagonist or agonist protocol). However, these studies do not concern blocking
with dienogest, a progestin whose use has recently been extended due to the generic drug's
marketing authorization obtained in 2019.
Ovarian stimulation with dienogest has therefore received very little attention in the
literature. The only study on this subject is a prospective study comparing dydrogesterone
and dienogest during ovarian stimulation for IVF. The number of mature oocytes collected was
significantly lower in the dienogest group, but the 2 groups were not comparable,
particularly in terms of AMH and CFA, which were significantly lower in the dienogest group,
making the results difficult to interpret.
Further studies therefore seem necessary to investigate the impact of dienogest blockade on
ovarian response, given the benefits brought by this treatment in terms of ease of use and
clinical tolerance in patients with endometriosis.
