Subcutaneous Progesterone Supplementation in Patients With Endometriosis
- Registration Number
- NCT02793908
- Lead Sponsor
- University Magna Graecia
- 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
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 52
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Pleyris Pleyris Subcutaneous progesterone will be administered 25 mg a day from the day following the ovulation for 14 days Crinone8 Crinone8 Vaginal progesterone will be administered 90 mg a day from the day following the ovulation for 14 days
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Magna Graecia University - Azienda Ospedaliera Pugliese Ciaccio
🇮🇹Catanzaro, CZ, Italy