Does Local Injury of the Endometrium Improve Controlled Ovarian Hyperstimulation (COH) + Intrauterine Insemination (IUI) Outcome?

Study Overview
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Brief Summary
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It was previously demonstrated in in vitro fertilization (IVF) patients that local injury of the endometrium during a spontaneous menstrual cycle that precedes IVF treatment doubled the rates of implantation and pregnancy. The hypothesis of our present study is that the endometrial injury procedure will have the same beneficial effect in patients undergoing controlled ovarian hyperstimulation (COH) combined with intrauterine insemination (IUI).

Detailed Description
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In order to test our hypothesis, we will perform the simple procedure of local injury of the endometrium using a Pipelle biopsy catheter during the spontaneous menstrual cycle that precedes a COH + IUI treatment.

Official Title
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Exploration of the Possibility That Local Injury of the Endometrium Has the Same Beneficial Effect on IUI Outcome as Demonstrated in IVF Treatment

Conditions
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Infertility, Implantation Failure

Intervention / Treatment
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* Procedure: endometrial biopsy
* Procedure: endometrial biopsy
* Procedure: natural cycle + IUI + endometrial biopsy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age 18-38. infertility. patients undergoing IUI treatment. at least one failed IUI cycle. Exclusion Criteria: indication for IVF treatment. Known Pelvic inflammatory disease(PID).

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: Clomiphene citrate + IUI + endometrial biopsy<br>Clomiphene citrate + IUI + endometrial biopsy | Procedure: endometrial biopsy<br>* two endometrial biopsies will be taken with a PIPELLE catheter on days 12 and 21 of the spontaneous menstrual cycle that precedes the fertility treatment.<br>|
| No Intervention: Clomiphene citrate + IUI<br> | |
| Experimental: gonadotrophines + IUI + endometrial biopsy<br>two endometrial biopsies will be taken with a PIPELLE catheter on days 12 and 21 of the spontaneous menstrual cycle that precedes the fertility treatment. | Procedure: endometrial biopsy<br>* two endometrial biopsies will be taken with a PIPELLE catheter on days 12 and 21 of the spontaneous menstrual cycle that precedes the fertility treatment.<br>|
| No Intervention: gonadotrophines + IUI<br> | |
| Experimental: natural cycle + IUI + endometrail biopsy<br>two endometrial biopsies will be taken with a PIPELLE catheter on days 12 and 21 of the spontaneous menstrual cycle that precedes the fertility treatment. | Procedure: natural cycle + IUI + endometrial biopsy<br>* two endometrial biopsies will be taken with a PIPELLE catheter on days 12 and 21 of the spontaneous menstrual cycle that precedes the fertility treatment.<br>|
| No Intervention: natural cycle + IUI<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Pregnancy rate |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Live birth |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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endometrial biopsy, implantation, uterine receptivity, infertility, controled ovarian hyperstimulation, intra uterine insemination