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The aim of the study protocol will be to compare the efficacy of subcutaneous progesterone (25 mg / day; Pleyris, IBSA Institut Biochimique SA) with vaginal progesterone (90 mg / day; Crinone, Merck Serono) administered during the luteal phase in term of pelvic pain reduction in patients with grade I-II endometriosis and / or endometrioma <4 cm subjected to time intercourses or COS/IUI cycles.
Patients with grade I-II endometriosis and / or endometrioma <4 cm subjected to time intercourses or COS/IUI cycles will be subjected to subcutaneous or vaginal progesterone for their luteal phase supplementation in time intercourses or IUI cycles.
The aim of the study protocol will be to compare the efficacy of subcutaneous progesterone (25 mg / day; Pleyris, IBSA Institut Biochimique SA) with vaginal progesterone (90 mg / day; Crinone, Merck Serono) administered during the luteal phase in term of pelvic pain reduction
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pleyris | Experimental | Subcutaneous progesterone will be administered 25 mg a day from the day following the ovulation for 14 days |
|
| Crinone8 | Active Comparator | Vaginal progesterone will be administered 90 mg a day from the day following the ovulation for 14 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pleyris | Drug | Luteal phase will be supplemented starting by the ovulation day for 14 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Delta VAS pain | Patients will be asked to score their menstrual pain using a VAS scale | 7 days after the end of the menstrual period subsequent to the luteal supplementation |
| Measure | Description | Time Frame |
|---|---|---|
| Analgesic use | Patients will be asked how many vials of analgesics they needed during their menstrual period | 7 days after the end of the menstrual period subsequent to the luteal supplementation |
| Pregnancy rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fulvio Zullo, MD, PhD | Contact | 337947003 | zullo@unicz.it |
| Name | Affiliation | Role |
|---|---|---|
| Fulvio Zullo | Magna Graecia University of Catanzaro | Study Director |
| Roberta Venturella | Magna Graecia University of Catanzaro | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Magna Graecia University - Azienda Ospedaliera Pugliese Ciaccio | Recruiting | Catanzaro | CZ | 88100 | Italy |
Data will be published at the end of the study.
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| ID | Term |
|---|---|
| D004715 | Endometriosis |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| Crinone8 | Drug | Luteal phase will be supplemented starting by the ovulation day for 14 days |
|
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The percentage of pregnancies achieved in both arms will be assessed
| 30 days after the end of the menstrual period subsequent to the luteal supplementation |
| D000091662 | Genital Diseases |