Subcutaneous Progesterone Supplementation in Patients With Endometriosis (PleyrisEndom)

University Magna Graecia

Status and phase: Unknown; Phase 3

Conditions: Endometriosis

Treatments: Drug: Pleyris; Drug: Crinone8

Study type: Interventional

Funder types: Other

Identifiers

NCT02793908

UMagnaGraecia

Details and patient eligibility

About

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.

Full 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

Enrollment: 52 estimated patients

Sex: Female

Ages: 18 to 38 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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52 participants in 2 patient groups

Pleyris

Experimental group

Description:

Subcutaneous progesterone will be administered 25 mg a day from the day following the ovulation for 14 days

Treatment:

Drug: Pleyris

Crinone8

Active Comparator group

Description:

Vaginal progesterone will be administered 90 mg a day from the day following the ovulation for 14 days

Treatment:

Drug: Crinone8