Clinical Trial Details
— Status: Withdrawn
Administrative data
| NCT number |
NCT05405686 |
| Other study ID # |
LHinPOR |
| Secondary ID |
|
| Status |
Withdrawn |
| Phase |
Phase 4
|
| First received |
|
| Last updated |
|
| Start date |
May 1, 2023 |
| Est. completion date |
August 1, 2024 |
Study information
| Verified date |
February 2024 |
| Source |
CRG UZ Brussel |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
This is a prospective randomized open-label cross-over study. Poor responder patients will
undergo two ovarian stimulation cycles. One with recombinant follicle stimulation hormone
(FSH), and an other stimulation with recombinant FSH and recombinant luteinizing hormone
(LH). In both groups, a freeze-all strategy will be applied and an endometrial biopsy will be
taken 7 days after final oocyte maturation trigger. Endometrial gene expression analysis will
be performed on both biopsies. After completion of both treatment cycles, a frozen embryo
transfer of a single embryo will be performed.
Description:
This is a prospective randomized open-label cross-over study, in which patients will be
randomized to either start in the control group or in the study group. Participants will
undergo both treatments with an interval of minimum 1 and maximum 6 months. In both treatment
arms, ovarian stimulation will be started at day 2/3 of the menstrual cycle. In the control
group, 225 IU of recombinant FSH will be administered in a fixed antagonist protocol. In the
study group, 225 IU of recombinant FSH plus 112,5 IU of recombinant LH will be administered.
Cycle monitoring will be performed through serum estradiol (E2), progesterone (P), and
luteinizing hormone (LH) assessments, combined with serial ultrasound examinations. Both
groups will undergo dual triggering with gonadotropin releasing hormone agonist (GnRHa) 0,2ml
and human chorionic gonadotrophin (hCG) 6500IU if one or more follicles of ≥ 17 mm are
observed. The oocyte retrieval (OR) will be performed between 34 and 36 hours after final
oocyte maturation trigger. At each OR, follicles will be individually meas-ured, aspirated
and searched for the presence of cumulus oocyte complexes (COC). Metaphase II (MII) oocytes
will then be injected to standard intra-cytoplasmatic sperm injection (ICSI) procedures. In
both groups, a freeze-all strategy will be applied. An endometrial biopsy (Pipelle de Cornier
®) will be taken 7 days after final oocyte maturation trigger. After completion of both
treatment cycles, a frozen embryo transfer of a single embryo will be performed.
