Endometrial Injury Versus Luteal Phase Support in Intrauterine Insemination Cycles

Study Overview
=================
Brief Summary
-----------------
The investigators will try to assess the effect of endometrial injury preceding the intrauterine insemination cycle on the pregnancy rates compared to cycles with luteal phase support and the control group.

Detailed Description
-----------------
Group 1: Endometrial biopsy is performed on days 21-24 of the spontaneous menstrual cycle proceeding the intrauterine insemination (IUI) treatment cycle. Two small biopsies are obtained from anterior and posterior walls of the uterus. Group 2: Vaginal progesterone gel is administered for luteal phase support from second day after insemination until pregnancy testing and is continued in the presence of pregnancy until the 12 weeks of pregnancy. Goup 3: Patients are undergone intrauterine insemination (IUI) cycles stimulated with gonadotropin without any intervention. The effect of endometrial injury and luteal phase progesterone support on the pregnancy rate in patients intrauterine insemination (IUI) cycles stimulated with gonadotropin will be compared in terms of biochemical pregnancy rate, clinical pregnancy rate and ongoing pregnancy rate.

Official Title
-----------------
Endometrial Injury Versus Luteal Phase Support in Intrauterine Insemination Cycles

Conditions
-----------------
Pregnancy

Intervention / Treatment
-----------------
* Other: Endometrial Injury
* Drug: progesterone (Crinone® %8 vaginal progesterone gel)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients are undergone intrauterine insemination with gonadotropin stimulation Bilateral patent fallopian tubes revealed by hysterosalpingography or laparoscopy After semen preparation for intrauterine insemination, total progressive sperm count > 5 million Exclusion Criteria: endocrin or metabolic disorders, uterine factor, pelvic inflammatory disease, women with basal follicle-stimulating hormone (FSH) level >15 IU/mL, body mass index (BMI) ≥ 35 kg/m2, age ≥ 40 and < 18 years,

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Endometrial Injury<br>Endometrial injury in luteal phase of preceding IUI cycle | Other: Endometrial Injury<br>* Endometrial injury in luteal phase of preceding cycle by pipelle canula<br>|
| Active Comparator: Luteal Phase Support<br>Luteal phase support with progesterone (Crinone® %8 vaginal progesterone gel) in IUI cycle Vaginal progesterone gel is administered from second day after insemination until pregnancy testing and is continued in the presence of pregnancy until the 12 weeks of pregnancy. | Drug: progesterone (Crinone® %8 vaginal progesterone gel)<br>* Luteal phase support with progesterone (Crinone® %8 vaginal progesterone gel) in IUI cycle Vaginal progesterone gel is administered from second day after insemination until pregnancy testing and is continued in the presence of pregnancy until the 12 weeks of pregnancy.<br>|
| No Intervention: Control group<br>Only IUI | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pregnancy Rate | ongoing pregnancy rates | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
intrauterine insemination, pregnancy rate, endometrial injury