Oral GnRH Antagonist (Linzagolix) Versus Injectable GnRH Antagonist in Controlled Ovarian Stimulation for In Vitro Fertilization: A Randomized Controlled Non-Inferiority Trial With a Concurrent Comparator Cohort Undergoing Progestin-Primed Ovarian Stimulation (PPOS)
Women undergoing IVF/ICSI who are candidates for a GnRH-antagonist protocol are randomly assigned 1:1 to oral linzagolix or the standard injectable GnRH antagonist (ganirelix or cetrorelix). A third, non-randomized group of women with a clinical indication for progestin-primed ovarian stimulation (PPOS) - for example, a need for a freeze-all strategy - is enrolled concurrently as a comparator cohort. The randomized comparison (linzagolix vs. injectable antagonist) is the primary, non-inferiority analysis; the PPOS cohort provides an exploratory, non-randomized comparison, analyzed with adjustment for baseline differences.
Studie Overzicht
Toestand
Conditie
Gedetailleerde beschrijving
This is a single-center, prospective, randomized, controlled non-inferiority trial with a concurrent non-randomized comparator cohort, conducted at CENTRO AMBRA. Women eligible for a GnRH-antagonist protocol are randomized 1:1 to oral linzagolix or the injectable GnRH antagonist using a computer-generated permuted-block randomization sequence (block size of 4, no stratification); allocation is concealed until treatment initiation. A separate, concurrent cohort of women with a clinical indication for PPOS is enrolled as a non-randomized comparator; because assignment to this cohort reflects clinical criteria, it may differ systematically from the randomized arms - confounding by indication limited to the PPOS comparison. This is addressed through pre-specified multivariable adjustment and, where sample size permits, propensity-score methods; the PPOS comparison is interpreted as an association, the randomized comparison as supporting non-inferiority. As treatment is known to investigators and patients, there is no masking (open-label); oocyte and embryo assessment follows standardized, predefined procedures. A target of 40 participants per group (120 total) was defined based on the pre-specified non-inferiority margin of 2.0 MII oocytes. All participants undergo a routine clinical follow-up visit 5 days after oocyte pick-up."
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- Female, aged 18 to 42 years
- Indication for IVF/ICSI with controlled ovarian stimulation at CENTRO AMBRA
- Population unselected for ovarian reserve (normal, poor, and high responders are eligible)
- Written informed consent, including consent for off-label use of linzagolix and for data processing
- For the two antagonist arms (Linzagolix and Injectable GnRH Antagonist): acceptance of randomization
Exclusion Criteria:
- Known contraindications or hypersensitivity to the study drugs
- Uterine pathology relevant to the study outcome (e.g., uterine malformations, significant submucosal fibroids)
- Contraindications to pregnancy or to ovarian stimulation
- Concurrent participation in another interfering interventional study
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: A - Linzagolix
|
Description: Linzagolix Type: Drug Group: A Description: Linzagolix 200 mg administered orally once daily, started per center protocol (fixed stimulation day or upon appearance of the dominant follicle) and continued through the day of trigger. Investigational off-label use for suppression of the premature LH surge during controlled ovarian stimulation. |
|
Actieve vergelijker: B - Injectable GnRH Antagonist (Ganirelix/Cetrorelix)
|
Ganirelix Type: Drug Group: B Description: Ganirelix acetate 0.25 mg administered by daily subcutaneous injection, per fixed or flexible protocol according to center practice, to suppress the premature LH surge during controlled ovarian stimulation. Cetrorelix Type: Drug Arm: B Description: Cetrorelix acetate 0.25 mg administered by daily subcutaneous injection, per fixed or flexible protocol according to center practice, to suppress the premature LH surge during controlled ovarian stimulation. |
|
Actieve vergelijker: C - PPOS (Progestin-Primed Ovarian Stimulation) Cohort
|
This is a non-randomized, concurrently enrolled comparator cohort (not part of the 1:1 randomization). Medroxyprogesterone Acetate - Type: Drug - Arm: C - Description: Medroxyprogesterone acetate 10 mg/day administered orally from stimulation day 1-2 through the day of trigger, as part of a progestin-primed ovarian stimulation (PPOS) protocol with mandatory freeze-all strategy. Micronized Progesterone - Type: Drug - Arm: C - Description: Micronized progesterone 100-200 mg/day administered orally from stimulation day 1-2 through the day of trigger, as part of a progestin-primed ovarian stimulation (PPOS) protocol with mandatory freeze-all strategy. |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Number of Mature (MII) Oocytes Retrieved
Tijdsspanne: At oocyte retrieval, approximately 36 hours after trigger (first study cycle)
|
Number of metaphase II (mature) oocytes collected at oocyte retrieval. Non-inferiority of linzagolix versus the injectable GnRH antagonist will be concluded if the lower bound of the 95% confidence interval for the adjusted mean difference in MII oocytes (adjusted for ovarian reserve, age, BMI, gonadotropin type and dose, and trigger type) excludes a loss greater than the pre-specified non-inferiority margin of 2.0 MII oocytes. An exploratory comparison with the PPOS cohort is also performed, adjusted for baseline confounders. |
At oocyte retrieval, approximately 36 hours after trigger (first study cycle)
|
Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
|
Incidence of Premature LH Rise
Tijdsspanne: From initiation of LH-suppressive treatment to the day of trigger (up to approximately 12 days)
|
From initiation of LH-suppressive treatment to the day of trigger (up to approximately 12 days)
|
Medewerkers en onderzoekers
Studie record data
Bestudeer belangrijke data
Studie start (Geschat)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- Urogenitale ziekten
- Genitale ziekten
- Vrouwelijke urogenitale ziekten
- Vrouwelijke urogenitale ziekten en zwangerschapscomplicaties
- Genitale ziekten, vrouw
- Onvruchtbaarheid
- Onvruchtbaarheid, vrouw
- Hormonen
- Hormonen, hormoonvervangers en hormoonantagonisten
- Polycyclische verbindingen
- Zwangere
- Steroïden
- Verbindingen met gefuseerde ring
- Gonadale steroïde hormonen
- Gonadale hormonen
- Zwangeringen
- Zwangeres
- Medroxyprogesteron
- Hydroxyprogesterones
- Corpus luteum hormonen
- Progesteron congeners
- Medroxyprogesteronacetaat
- Progesteron
- Ganirelix
- cetrorelix
- linzagolix
Andere studie-ID-nummers
- LINZA-COS
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
product vervaardigd in en geëxporteerd uit de V.S.
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