Use of Omalizumab will increase the pregnancy rate, proof of concept study, where women with asthma and infertility will be treated three times with weight and IgE balanced dosis at the sixth day of their period bleeding.

Use of Omalizumab will increase the pregnancy rate, proof of concept study, where women with asthma and infertility will be treated three times with weight and IgE balanced dosis at the sixth day of their period bleeding. - Use of Omalizumab will increase the pregnancy rate, proof of concept study, where women with asthma

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-001137-41-DK

Enrollment

180

Registered

2018-04-25

Start date

2018-06-26

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

infertility within female asthma patients as a result of systemic inflamation.

Interventions

Trade Name: Xolair Pharmaceutical Form: Injection INN or Proposed INN: OMALIZUMAB CAS Number: 242138-07-4 Current Sponsor code: omalizumab Other descriptive name: xolair Concentration unit: mg/ml mill

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: * 18-40 years old • Informed consent • Diagnosis of asthma with or without allergy • Infertility due to male factor infertility, tubal factor infertility or unexplained infertility. • Referred to IVF treatment with or without ICSI • Willingness to receive treatment with biologic drugs during menstruation period • Controlled disease with an ACQ = 1.5 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 180 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: • Other respiratory diseases than asthma • Other inflammatory disease or a disease that affects fertility. • Allergy to the investigational drugs • Respiratory infections requiring antibiotics or anti-viral treatment within 30 days • TESA / TESE, Endometriosis • Infertility due to other reasons than male factor, tubal factor or unexplained infertility

Design outcomes

Primary

Measure	Time frame
Main Objective: To compare, pregnancy rates in asthma patients undergoing IVF/ICSI treatment when treated with either omalizumab or placebo in up to three consecutive fertility treatments with embryo transfer. The primary endpoint is pregnancy confirmed by ultra sound in week 7.;Secondary Objective: A) Change in Sputum and blood Eosinophilic cell count (before treatment and after treatment). B) Change in VEGF, CRP, IL6, IL8, IgE, TNFa, ECP in blood, sputum and uterus secretion (before treatment, and after treatment). C) Changes in the microbiota in sputum (before treatment and after treatment). D) Change in airway inflammation, the inflammatory markers in the blood, the inflammation in the uterus and the sex hormones before and after treatment. E) Rate of pregnancy loss: Difference between positive s-hCG and ongoing pregnancy week 7, week 12, and birth – number of malformation , preterm, preeclampsia, perinatal death, SGA, birth weight in both groups. F) Primary outcome in relation to length of infertility prior to referral and TTP ;Primary end point(s): The pregnancy rate, measured as birt or loss of pregnancy after three consecutive IVF cycles ;Timepoint(s) of evaluation of this end point: 31 december 2024	—

Measure

Time frame

Main Objective: To compare, pregnancy rates in asthma patients undergoing IVF/ICSI treatment when treated with either omalizumab or placebo in up to three consecutive fertility treatments with embryo transfer. The primary endpoint is pregnancy confirmed by ultra sound in week 7.;Secondary Objective: A) Change in Sputum and blood Eosinophilic cell count (before treatment and after treatment). B) Change in VEGF, CRP, IL6, IL8, IgE, TNFa, ECP in blood, sputum and uterus secretion (before treatment, and after treatment). C) Changes in the microbiota in sputum (before treatment and after treatment). D) Change in airway inflammation, the inflammatory markers in the blood, the inflammation in the uterus and the sex hormones before and after treatment. E) Rate of pregnancy loss: Difference between positive s-hCG and ongoing pregnancy week 7, week 12, and birth – number of malformation , preterm, preeclampsia, perinatal death, SGA, birth weight in both groups. F) Primary outcome in relation to length of infertility prior to referral and TTP ;Primary end point(s): The pregnancy rate, measured as birt or loss of pregnancy after three consecutive IVF cycles ;Timepoint(s) of evaluation of this end point: 31 december 2024

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Secondary

Measure	Time frame
Secondary end point(s): 1st day of menstruation, 6th day of menstruation, at time of ovulation (both treatments). A) Change in Sputum and blood Eosinophilic cell count (before treatment and after treatment) B) Change in VEGF, CRP, IL6, IL8, IgE, TNFa, ECP in blood, sputum and uterus secretion (before treatment, and after treatment). No collections will be done during the menstruation period. C) Changes in the microbiota in sputum (before treatment and after treatment). No collections will be done during menstruation period. D) Change in airway inflammation, the inflammatory markers in the blood, the inflammation in the uterus secretion and the sex hormones before and after treatment. E) Rate of miscarriages: ongoing s-hCG week 7, ongoing s-hCG week 12, and birth. – number of malformation , preterm, preeclampsia, perinatal death, SGA, birth weight in both groups. F) Total time from first attempt at conceiving to first treatment day, adjusted TTP. End points sub-study: A) Number of malformations and/or other conditions of the children born in the study B) Descriptive information about sex, weight, height C) Information from (if any) lab samples etc. ;Timepoint(s) of evaluation of this end point: 31 december 2029	—

Measure

Time frame

Secondary end point(s): 1st day of menstruation, 6th day of menstruation, at time of ovulation (both treatments). A) Change in Sputum and blood Eosinophilic cell count (before treatment and after treatment) B) Change in VEGF, CRP, IL6, IL8, IgE, TNFa, ECP in blood, sputum and uterus secretion (before treatment, and after treatment). No collections will be done during the menstruation period. C) Changes in the microbiota in sputum (before treatment and after treatment). No collections will be done during menstruation period. D) Change in airway inflammation, the inflammatory markers in the blood, the inflammation in the uterus secretion and the sex hormones before and after treatment. E) Rate of miscarriages: ongoing s-hCG week 7, ongoing s-hCG week 12, and birth. – number of malformation , preterm, preeclampsia, perinatal death, SGA, birth weight in both groups. F) Total time from first attempt at conceiving to first treatment day, adjusted TTP. End points sub-study: A) Number of malformations and/or other conditions of the children born in the study B) Descriptive information about sex, weight, height C) Information from (if any) lab samples etc. ;Timepoint(s) of evaluation of this end point: 31 december 2029

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Countries

Denmark

Contacts

Public ContactHvidovre Hospital

Hvidovre Hospital. Dep of Respiratory Medicin

csulrik@dadlnet.dk004538623825

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026