Treatment With the Anti-IgE Monoclonal Antibody Omalizumab in Women With Asthma Undergoing Fertility Treatment. - A Proof of Concept Study.

PHASE2CompletedINTERVENTIONAL
Enrollment

66

Participants

Timeline

Start Date

January 1, 2019

Primary Completion Date

December 31, 2024

Study Completion Date

December 31, 2024

Conditions
AsthmaInfertility, Female
Interventions
DRUG

Omalizumab Injection

The treatment is initiated with one injection with weight and serum-immunoglobulin E balanced omalizumab. After omalizumab treatment at ovulation it will again be collected material (blood samples, sputum, secretion of the vagina, secretion of the rectum, secretion of the uterus, microbiota). If no pregnancy has occurred after first IVF cycle, this will be repeated for 3 consecutive IVF cycles in total or until pregnancy has occurred.

DRUG

NaCl

The treatment is initiated with one injection with placebo. After placebo injection treatment at ovulation it will again be collected material (blood samples, sputum, secretion of the vagina, secretion of the rectum, secretion of the uterus, microbiota). If no pregnancy has occurred after first IVF cycle, this will be repeated for 3 consecutive IVF cycles in total or until pregnancy has occurred.

Trial Locations (1)

DK-2100

Charlotte Suppli Ulrik, Copenhagen

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Novartis

INDUSTRY

collaborator

Hvidovre University Hospital

OTHER

collaborator

Herlev Hospital

OTHER

collaborator

Zealand University Hospital

OTHER

lead

Rigshospitalet, Denmark

OTHER

NCT03727971 - Treatment With the Anti-IgE Monoclonal Antibody Omalizumab in Women With Asthma Undergoing Fertility Treatment. - A Proof of Concept Study. | Biotech Hunter | Biotech Hunter