Subcutaneous Progesterone Supplementation in Patients With Endometriosis

Study Overview
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Brief Summary
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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
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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

Official Title
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The Role of the Subcutaneous Progesterone in Luteal Phase Supplementation in Patients With Endometriosis

Conditions
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Endometriosis

Intervention / Treatment
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* Drug: Pleyris
* Drug: Crinone8


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 38 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pleyris<br>Subcutaneous progesterone will be administered 25 mg a day from the day following the ovulation for 14 days | Drug: Pleyris<br>* Luteal phase will be supplemented starting by the ovulation day for 14 days<br>* Other names: Subcutaneous progesterone;|
| Active Comparator: Crinone8<br>Vaginal progesterone will be administered 90 mg a day from the day following the ovulation for 14 days | Drug: Crinone8<br>* Luteal phase will be supplemented starting by the ovulation day for 14 days<br>* Other names: vaginal progesterone;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Delta VAS pain | Patients will be asked to score their menstrual pain using a VAS scale | 7 days after the end of the menstrual period subsequent to the luteal supplementation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analgesic use | Patients will be asked how many vials of analgesics they needed during their menstrual period | 7 days after the end of the menstrual period subsequent to the luteal supplementation | 
| Pregnancy rate | The percentage of pregnancies achieved in both arms will be assessed | 30 days after the end of the menstrual period subsequent to the luteal supplementation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Endometriosis, Subcutaneous progesterone, luteal phase