Effects of Co-treatment on Endometrial abv3-integrin Expressions in Women With Recurrent Implantation Failure

Study Overview
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Brief Summary
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To compare the abv3-integrin expression in endometrium tissue among RIF women between the GnRH analogue with Aromatase Inhibitor (Group A) , GnRH analogue with progesterone (Group B) and GnRH analogue alone as control group (Group C)

Detailed Description
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i. To determine the abv3-integrin expression isolated from endometrium tissue from women with RIF prior to medical therapy. ii. To determine the abv3-integrin expression isolated from endometrium tissue from Group A, Group B and Group C following the medical therapy. iii. To compare the abv3-integrin expression from endometrium tissue obtained from Group A, B and C following the medical therapy. iv. To compare the implantation rates among Group A, B and C following the medical therapy. v. To compare the ongoing pregnancy among Group A, B and C following the medical therapy

Official Title
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Effects of Co-treatment With Aromatase Inhibitor or Progestin on Endometrial abv3-integrin Expressions in Women With Recurrent Implantation Failure

Conditions
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Miscarriage, Recurrent

Intervention / Treatment
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* Drug: GNRH Analoge, Duphaston, Letrozole


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women of 18 to 40 years of age No significant pre-existing major medical. Diagnosed as recurrent implantation failure - at least two or more failure of achieving pregnancy following embryo transfer (ET) despite the optimum endometrial thickness and good quality of embryo (unexplained). Regular menstrual cycle atleast 3 months prior to treatment Not taking any hormonal treatment for atlest 3months prior to recruitment Agreed to participate Exclusion Criteria: Concurrent significant pre-existing major medical conditions such as uncontrolled diabetes, active systemic lupus erythematosus (SLE) or Anti Phospholipid Syndrome (APS) that will interfere with implantation. Poor quality of embryo Suboptimal endometrial thickness(<8mm) during the embryo transfer (ET). On hormonal therapy prior to recruitment. Not agreed to participate

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

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: All recruited women will be allocated in three groups, and endometrial tissue sampling will be obtained prior to medical intervention assigned during luteal phase depending on their menstrual cycle. All these women will be divided randomly in three groups A, B & C equally by using the auto-randomized program in SPSS version 21.0.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A (GnRH analogue with Aromatase Inhibitor<br>This group of candidates will be administered a single dose of 11.25mg GNRH analoge (Lucrin) followed by Letroloze 10mg OD for 3 months | Drug: GNRH Analoge, Duphaston, Letrozole<br>* GNRH Analoge, Duphaston, Letrozole<br>|
| Active Comparator: Group B (GnRH analogue with Progesterone<br>This group of candidates will be administered a single dose of 11.25mg GNRH analoge (Lucrin) followed Duphaston 10mg BD by for 3 months | Drug: GNRH Analoge, Duphaston, Letrozole<br>* GNRH Analoge, Duphaston, Letrozole<br>|
| Placebo Comparator: Group C (GnRH analogue alone)<br>This is a control group. The candidates will be administered a single dose of 11.25mg GNRH analoge (Lucrin) only. | Drug: GNRH Analoge, Duphaston, Letrozole<br>* GNRH Analoge, Duphaston, Letrozole<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| endometrial abv3-integrin expression expressions | pre and post treatment endometrial abv3-integrin expressions | 12 months |