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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-002321-11 | EudraCT Number |
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This study is a prospective randomized trial with 242 IUI cycles. Patients are randomized in two groups including 121 cycles in each group. A total of 255 cycles in 167 patients are finally recruited. In the first group, the patients will be treated with triptorelin (Gonapeptyl®) in their luteal phase. As for the other group, the patients will undergo the luteal phase without any supportive medication. This study is going to clarify the role of the gonadotropin agonist (triptorelin acetate, Gonapeptyl®) as a luteal phase supporter. The benefit of the treatment is measured by the numbers in the live birth and clinical pregnancy rates.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gonapeptyl | Experimental | In the intervention group the patient will get the advice to using triptorelin (Gonapeptyl®) in the eight day after the injection of hCG (Pregnyl®) in the insemination cycle. |
|
| Control group | No Intervention | In the control group, there are no luteal phase medications in the insemination cycle. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Triptorelin | Drug | Triptorelin 0,1mg/ml subcutaneously once in a luteal phase in insemination cycles. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Live birth rate | At possible delivery (about 40 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Ongoing pregnancy rate | After two weeks | |
| Miscarriage rate | During subsequent about 40 weeks of pregnancy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Helena Tinkanen | Tampere University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tampere University Hospital | Tampere | Finland |
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| ID | Term |
|---|---|
| D007247 | Infertility, Female |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D017329 | Triptorelin Pamoate |
| ID | Term |
|---|---|
| D007987 | Gonadotropin-Releasing Hormone |
| D010906 | Pituitary Hormone-Releasing Hormones |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
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| D000091662 | Genital Diseases |
| D007246 | Infertility |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |