Endometriosis Clinical Trial
— PleyrisEndomOfficial title:
The Role of the Subcutaneous Progesterone in Luteal Phase Supplementation in Patients With Endometriosis
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.
Status | Recruiting |
Enrollment | 52 |
Est. completion date | August 2017 |
Est. primary completion date | June 2017 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 38 Years |
Eligibility |
Inclusion Criteria: - Laparoscopic or ultrasonographic diagnosis of endometriosis grade I-II and / or endometrioma <4 cm; - Menstrual VAS score> 5 cm before the last menstrual period with progesterone treatment - Infertility for at least 1 year - Body Mass Index 19 to 30 kg / m2 - Basal FSH serum <15 IU / ml - Normal levels of serum prolactin - Normal uterine cavity and fallopian patency Exclusion Criteria: - Previous ovarian surgery - Endocrine disorders (eg polycystic ovary syndrome, thyroid disease, hyperprolactinemia, hypogonadotropic hypogonadism) - Reduced ovarian reserve (basal levels of FSH> 15 IU / mL) - Acute or chronic infectious state - Chronic drug intake, alcohol, or drugs that affect cognitive functions, alertness and / or mood - Psychiatric disorders - Kidney or liver diseases - Male factor infertility |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Italy | Magna Graecia University - Azienda Ospedaliera Pugliese Ciaccio | Catanzaro | CZ |
Lead Sponsor | Collaborator |
---|---|
University Magna Graecia |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
Secondary | 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 | No |
Secondary | Pregnancy rate | 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 | No |
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