Subcutaneous Progesterone Supplementation in Patients With Endometriosis

• Status: Unknown status
• Trial end date: 2017-08-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Magna Graecia
• Treatments: Progesterone

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