Einleitung wieder einblenden
NCT03809429

Follitropin Delta in Long GnRH Agonist and GnRH Antagonist Protocols (BEYOND)

Datenbasis: WHO (Import vom 22.09.2019)
Geändert: 22.09.2019
Krankheitskategorie:

Health conditions (Datenquelle: WHO)

Infertility, Female

Interventions (Datenquelle: WHO)

Drug: FE 999049 + GnRH agonist (GONAPEPTYL);Drug: FE 999049 + GnRH antagonist (CETROTIDE)

Inclusion/Exclusion Criteria (Datenquelle: WHO)


Inclusion Criteria:

- Infertile women aged 18-40 undergoing their first IVF/ICSI cycle that are in good
physical and mental health and that have been diagnosed with problems in the fallopian
tubes, mild endometriosis or have partners with decreased sperm quality.

- The participants must have a regular menstrual cycle, a normal uterus and 2 normal
ovaries.

- The allowed body mass index is 17.5-32 Kg/m^2.

Exclusion Criteria:

- Women with very high ovarian reserve, strong preference for either treatment, severe
endometriosis, history of repeated miscarriage, couples with known problems in the
chromosomes, history or high risk of producing blood cloths, women known to have
chronic diseases, women recently participating in trials with non-registered drugs.

Weitere Angaben zur Studie im WHO-Primärregister

https://clinicaltrials.gov/show/NCT03809429

Weitere Angaben zur Studie aus der Datenbank der WHO (ICTRP)

http://apps.who.int/trialsearch/Trial2.aspx?TrialID=NCT03809429

Weitere Informationen zur Studie

Registrationsdatum der Studie

07.01.2019

Einschluss der ersten teilnehmenden Person

29.04.2019

Rekrutierungsstatus

Recruiting

Wissenschaftlicher Titel (Datenquelle: WHO)

A Randomised, Controlled, Open Label, Parallel Group, Multicentre Trial Comparing the Efficacy and Safety of Individualised FE 999049 (Follitropin Delta) Dosing, Using a Long GnRH Agonist Protocol and a GnRH Antagonist Protocol in Women Undergoing Controlled Ovarian Stimulation

Studientyp (Datenquelle: WHO)

Interventional

Design der Studie (Datenquelle: WHO)

Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).

Phase (Datenquelle: WHO)

Phase 3

Primäre Endpunkte (Datenquelle: WHO)

Number of oocytes retrieved

Sekundäre Endpunkte (Datenquelle: WHO)

Proportion of subjects with cycle cancellation due to poor ovarian response or excessive ovarian response;Proportion of subjects with blastocyst transfer cancellation after oocyte retrieval due to (risk of) ovarian hyperstimulation syndrome (OHSS);Number of follicles;Proportion of subjects with <4, 4-7, 8-14, 15-19 and =20 oocytes retrieved;Number of metaphase II oocytes;Fertilization rate;Number of embryos;Number of blastocysts;Circulating concentrations of follicle-stimulating hormone (FSH), luteinizing hormone (LH), estradiol, progesterone and inhibin B;Total gonadotropin dose;Number of stimulation days;Positive beta human chorionic gonadotropin (ßhCG) rate;Implantation rate;Clinical pregnancy rate;Vital pregnancy rate;Ongoing pregnancy rate;Ongoing implantation rate;Proportion of subjects with early OHSS (including OHSS of moderate/severe grade);Proportion of subjects with late OHSS (including OHSS of moderate/severe grade);Frequency of adverse events;Intensity of adverse events;Technical malfunctions of the pre-filled injection pen

Kontakt für Auskünfte (Datenquelle: WHO)

Please refer to primary and secondary sponsors

Studiendurchführungsorte

Durchführungsländer (Datenquelle: WHO)

Austria, Denmark, Israel, Italy, Netherlands, Norway, Switzerland

Kontakt für weitere Auskünfte zur Studie

Kontakt für allgemeine Auskünfte (Datenquelle: WHO)

Global Clinical Compliance
Ferring Pharmaceuticals
+1 833-548-1402 (US/Canada)
DK0-Disclosure@ferring.com

Kontakt für wissenschaftliche Auskünfte (Datenquelle: WHO)

Global Clinical Compliance
Ferring Pharmaceuticals
+1 833-548-1402 (US/Canada)
DK0-Disclosure@ferring.com

Studienverantwortliche

Hauptsponsor (Datenquelle: WHO)

Ferring Pharmaceuticals

Weitere Studienidentifikationsnummern

Secondary ID (Datenquelle: WHO)

2017-002783-40;000304