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This is a prospective randomised study of the evaluation of the clinical IVF results after following a new revolutionary 3-Injection- Protocol for controlled ovarian stimulation in infertile women.
A randomized prospective study focusing on infertile women undergoing ovarian stimulation for IVF, using Elonva (corifollitropin alfa) as part of two different stimulation protocols.
Women assigned to Protocol A receive a bolus late luteal dose of Degarelix, a new long acting GnRH antagonist, a sole Elonva injection in the evening of day 3 of the cycle, followed by the administration of a single dose of triggering agent (GnRH agonist or hCG a, according to the individual response).
Women assigned to Protocol B are administered a single dose of Elonva (corifollitropin alfa) on day 2 of the cycle, followed by daily GnRH antagonist doses, fixed on day 7 of the cycle. Ovulation triggering is the same as in group A, with either GnRH agonist or hCG a, accordingly.
Live Birth Rates are estimated for both groups of patients. The number of the formed blastocysts in each group is measured, as well.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 3-Injection-Protocol Group | Women in group A (3-Injection-Protocol Group) receive a bolus late luteal dose of Degarelix, a new long acting GnRH antagonist, a sole Elonva injection in the early follicular phase followed by the administration of a single dose of triggering agent (GnRH agonist or hCG a, according to the individual response). |
| |
| Multiple-Injection- Protocol Group | Women assigned to group B (Multiple- Injection- Protocol Group) are administered a single dose of Elonva (corifollitropin alfa) in the early follicular phase followed by daily GnRH antagonist doses, either fixed on day 6 of the stimulation cycle, or when 2 or 3 follicles over 12-14 mm are present. Ovulation triggering is the same as in group A, with either GnRH agonist or hCG a, accordingly. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Live birth rate | Diagnostic Test | Live Birth Rate and Blastulation Rate according to the protocol of COS |
|
| Measure | Description | Time Frame |
|---|---|---|
| Live birth rate according to stimulation protocol | Live birth rate according to stimulation protocol | Up to 38 weeks after embryo transfer |
| Measure | Description | Time Frame |
|---|---|---|
| Blastulation rate according to stimulation protocol | Blastulation rate according to stimulation protocol | Up to 6 days post oocyte retrieval |
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Inclusion Criteria:
Exclusion Criteria:
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Women aged 22- 39, faced with infertility issues, meeting the above inclusion criteria.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Evaggelos Papanikolaou, MD,PhD | Contact | 00302310424294 | drvagpapanikolaou@yahoo.gr |
| Name | Affiliation | Role |
|---|---|---|
| Evaggelos Papanikolaou, MD,PhD | Assisting Nature | Principal Investigator |
| Robert Najdecki, MD,PhD | Assisting Nature | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Assisting Nature | Recruiting | Thessaloniki | 57001 | Greece |
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| ID | Term |
|---|---|
| D007247 | Infertility, Female |
| D007246 | Infertility |
| 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 |
|---|---|
| D018873 | Pregnancy Rate |
| ID | Term |
|---|---|
| D014798 | Vital Statistics |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
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|
| D000091662 | Genital Diseases |
| D055703 |
| Reproductive Physiological Phenomena |
| D012101 | Reproductive and Urinary Physiological Phenomena |
| D003710 | Demography |
| D011154 | Population Characteristics |
| D015991 | Epidemiologic Measurements |
| D011634 | Public Health |
| D004778 | Environment and Public Health |