Endometriosis
Conditions
Keywords
Endometriosis, Subcutaneous progesterone, luteal phase
Brief summary
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.
Detailed description
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
Interventions
DRUGPleyris
Luteal phase will be supplemented starting by the ovulation day for 14 days
DRUGCrinone8
Luteal phase will be supplemented starting by the ovulation day for 14 days
Sponsors
University Magna Graecia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 38 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Delta VAS pain | 7 days after the end of the menstrual period subsequent to the luteal supplementation | Patients will be asked to score their menstrual pain using a VAS scale |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Analgesic use | 7 days after the end of the menstrual period subsequent to the luteal supplementation | Patients will be asked how many vials of analgesics they needed during their menstrual period |
| Pregnancy rate | 30 days after the end of the menstrual period subsequent to the luteal supplementation | The percentage of pregnancies achieved in both arms will be assessed |
Countries
Italy
Contacts
Primary ContactFulvio Zullo, MD, PhD
Outcome results
None listed