Endometrial Injury and IVF Outcome Parameters in Patients With Failed IVF Cycles

Study Overview
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Brief Summary
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The iatrogenic induction of local endometrial injury caused through hysteroscopy or pipelle sampling in the preceding non- transfer cycle improves the IVF outcome parameters in patients with previous IVF failures.

Detailed Description
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Endometrial injury was preformed either through hysteroscope during office hysteroscopy through the non touch technique or through pipelle biopsy in the early follicular phase (days 5 to 9) in the preceding cycle of the IVF treatment.

Official Title
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The Effect of Endometrial Injury on IVF Outcome Parameters in Patients With Repeated Implantation Failures

Conditions
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Repeated Implantation Failures

Intervention / Treatment
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* Procedure: Endometrial injury by hysteroscopy or pipelle sampling
* Procedure: Proceed to COH directly


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Personal history of 2 or more failed IVF/ICSI cycles (RIF) Age</= 42 years Good response with good quality embryos in previous attempts (>2) Exclusion Criteria: Personal history of endometrial tuberculosis/ antituberculous treatment Sonographically detected hydrosalpinges Intramural fibroids distorting the endometrial cavity, submucous myomas or Asherman's syndrome Thrombophilia

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 42 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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Endometrial injury by hysteroscopy or pipelle sapling<br>Endometrial Sampling by pipelle or hysteroscopy performed once between 6th to 10th day in the cycle prior to the fresh IVF/ ICSI cycle. | Procedure: Endometrial injury by hysteroscopy or pipelle sampling<br> <br> |
| Active Comparator: COH for IVF without hysteroscopy or pipelle sampling<br>Procedure: COH for IVF Both GnRH agonists (long, starting at day 2 or 21) with triptorelin acetate 0.1 mg (Gonapeptyl daily) and antagonists with ganirelix 0.25mg (Orgalutran) or cetrorelix 0.25mg (Cetrotide) protocols will be used; for ovarian stimulation both recombinant FSH ( Puregon) and human menopausal gonadotrophin ( Menopur) will be used. Ovarian response will be monitored by ultrasonography, oocyte retrieval will be performed 36-38 hours after the Hcg triggering and for luteal phase support 600 mg progesterone tablets ( Utrogestan) will be applied. | Procedure: Proceed to COH directly<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| positive bHCG rate |  | through study completion, an average of 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical pregnancy rate |  | 2 years | 
| live birth rate |  | 2 years | 
| Ectopic pregnancy rate |  | 2 years | 
| Miscarriage rate |  | 2 years | 
| Ongoing pregnancy rate |  | 2 years | 
| Pregnancy complications (preterm birth, placental abnormalities, bleeding throughout pregnancy, pregnancy related hypertensive disorders, IUGR and SGA) |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Failed IVF cycles, IVF outcome parameters, endometrial injury, hysteroscopy, pipelle sampling, Repeated implantation failures