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Prospective randomised controlled trial: 3 IUI cycles versus 1 IVF/ICSI cycle in women aged 38-42 years.
Study design:
Prospective randomised controlled trial: 3 IUI cycles versus 1 IVF/ICSI cycle in women aged 38-42 years. .
Group 1: 3 consecutive gonadotrophin stimulated IUI cycles (Follitropine BĆØta, Puregon, MSD).
vs. Group 2: 1 IVF/ ICSI cycle - Recombinant FSH (Follitropine BĆØta, Puregon, MSD) - Antagonist protocol.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IUI group | Active Comparator | Group 1: Patients undergo a standard treatment with 3 consecutive gonadotrophin stimulated IUI cycles Intervention: treatment choice and drug:(Follitropine BĆØta, Puregon, MSD). vs. |
|
| IVF/ICSI arm | Active Comparator | Group 2: 1 Patients start immediately with IVF/ICSI instead of IUI. A standard antagonist protocol with treatment with a recombinant FSH (Follitropine BĆØta, Puregon, MSD) is used. Intervention: treatment choice and drug: recombinant FSH (Follitropine BĆØta, Puregon, |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Drug: Follitropine BĆØta | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ongoing pregnancy rate | Study design: Prospective randomised controlled trial: 3 IUI cycles versus 1 IVF/ICSI cycle in women aged 38-42 years. Group 1: 3 consecutive gonadotrophin stimulated IUI cycles (Follitropine BĆØta, Puregon, MSD). vs. Group 2: 1 IVF/ ICSI cycle - Recombinant FSH (Follitropine BĆØta, Puregon, MSD) - Antagonist protocol. Primary endpoint: Comparison of the cumulative ongoing pregnancy rates after 3 IUI cycles versus 1 IVF/ICSI cycle. | 12 weeks |
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Inclusion Criteria:
Women aged between 38 and 42 years. Sperm: use of donor sperm or husband sperm reaching WHO criteria 2010.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael De Brucker, MD | Universitair Ziekenhuis Brussel | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UniversitairZB | Recruiting | Jette | Belgium |
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| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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