Clinical trial NCT02793908: Subcutaneous Progesterone Supplementation in Patients With Endometriosis
Official title: The Role of the Subcutaneous Progesterone in Luteal Phase Supplementation in Patients With Endometriosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Endometriosis
Keywords: Endometriosis
Subcutaneous progesterone
luteal phase
Lead sponsor: University Magna Graecia
Sponsor class: OTHER
First posted: 2016-06-08
Enrollment: 52
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Delta VAS pain
timeFrame: 7 days after the end of the menstrual period subsequent to the luteal supplementation
Secondary outcomes:
measure: Analgesic use
timeFrame: 7 days after the end of the menstrual period subsequent to the luteal supplementation
measure: Pregnancy rate
timeFrame: 30 days after the end of the menstrual period subsequent to the luteal supplementation
Other outcomes:
Locations:
city: Catanzaro
country: Italy
facility: Magna Graecia University - Azienda Ospedaliera Pugliese Ciaccio
state: CZ
Study officials:
affiliation: Magna Graecia University of Catanzaro
name: Fulvio Zullo
role: STUDY_DIRECTOR
affiliation: Magna Graecia University of Catanzaro
name: Roberta Venturella
role: PRINCIPAL_INVESTIGATOR
References: