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Luteal phase support in "in vitro fertilization" (IVF) cycles has been shown to improve pregnancy rates and became a standard of treatment, and progesterone is the first choice considering its safety profile and effectiveness. There are many studies demonstrating that vaginal progesterone is equally efficacious and better tolerated compared to intramuscular progesterone for luteal phase support in IVF cycles. Conversely, although different studies showed that subcutaneous progesterone is equally efficacious compared to vaginal progesterone, patient use satisfaction and compliance were less studied with few evidences are available, that may guide the choice of vaginal progesterone instead of subcutaneous progesterone and other way around. Considering the paucity of published data about the patient's preference and use satisfaction about subcutaneous progesterone, the investigators will conduct a prospective randomized study aimed to compared adverse effects rates, impact on quality of life, use satisfaction and administration preference in women undergoing luteal phase support with vaginal progesterone versus subcutaneous progesterone during IVF cycles, that may guide the choice for luteal phase support in IVF cycles.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subcutaneous progesterone | Active Comparator | After standard stimulating protocol for IVF, beginning on the day of oocyte retrieval allocated patients receive subcutaneous progesterone (Pleyris, IBSA Farmaceutici, Italia) 25 mg one time per day (every day at the same time, according to patient's availability and preference) for at least 8 gestational weeks or confirmation of a negative pregnancy test performed 14 days after oocyte retrieval. |
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| Vaginal progesterone | Active Comparator | After standard stimulating protocol for IVF, beginning on the day of oocyte retrieval allocated patients receive micronized vaginal progesterone (Progeffik, EFFIK Spa, Italia) 200 mg three times per day (every 8 hours) for at least 8 gestational weeks or confirmation of a negative pregnancy test performed 14 days after oocyte retrieval. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Subcutaneous Progesterone | Drug | Subcutaneous progesterone (Pleyris, IBSA Farmaceutici, Italia) 25 mg one time per day (every day at the same time, according to patient's availability and preference). |
| Measure | Description | Time Frame |
|---|---|---|
| Grade of use satisfaction reported by the patients | Patients will be asked how satisfied they are by the use of progesterone product that they receive in the luteal phase. Their satisfaction responses will be recorded on a scale of 1 to 3, with 1 being ''least satisfied'' and 3 being ''most satisfied'. | At the human chorionic gonadotropin test performed after 14 days of progesterone use |
| Grade of quality of life impairment reported by the patients | Patients will be asked whether work life, social life, sexual life, and personal hygiene are perceived impaired by the progesterone treatment that they received. The answer for each item is "yes" or "no". | At the human chorionic gonadotropin test performed after 14 days of progesterone use |
| Adverse effects (AEs) | Patients will be asked to report experienced AEs. The investigated AEs are sleepiness, dizziness, headache, bowel dysfunctions, breast pain/tension, weight changes, mood disorders, skin irritation, and vaginal discharge. The answer for each item is "yes" or "no". | At the human chorionic gonadotropin test performed after 14 days of progesterone use |
| Measure | Description | Time Frame |
|---|---|---|
| Progesterone administration route that the patients prefer | Patients of subcutaneous progesterone arm and who had previously used vaginal progesterone will be asked which administration route they prefer. | At the human chorionic gonadotropin test performed after 14 days of progesterone use |
| Implantation rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Simone Garzon, M.D. | Universita di Verona | Principal Investigator |
| Rossana Di Paola, M.D. | Universita di Verona | Principal Investigator |
| Antonio Simone Laganà | Università degli Studi dell'Insubria | Principal Investigator |
| Francesca Parissone, M.D. | Universita di Verona | Principal Investigator |
| Stefano Zaffagnini, M.D. | AOUI Verona | Study Director |
| Massimo Franchi, M.D. | Universita di Verona | Study Director |
| Ricciarda Raffaelli, M.D. | Universita di Verona | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AOUI Verona - University of Verona - Department of Obstetrics and Gynecology | Verona | 37125 | Italy |
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Prospective randomized trial
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| Vaginal progesterone | Drug | Micronized vaginal progesterone (Progeffik, EFFIK Spa, Italia) 200 mg three times per day (every 8 hours). |
|
Rate of positive human chorionic gonadotropin test |
| At the human chorionic gonadotropin test performed after 14 days of progesterone use |
| Clinically pregnancy rate | Rate of evolving pregnancy at ultrasound | At 6 week from oocyte retrieval |
| live birth rate | Rate of baby delivered after 24 gestational weeks | At nine months from oocyte retrieval |