Comparative Study of Three Different Embryo Transfer Media in ICSI Cycles

Study Overview
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Brief Summary
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The study design is a prospective randomized uncontrolled clinical trial. It will include 150 cases. The aim of this study is to compare the efficacy of three different media used for embryo transfer regarding chemical and clinical pregnancy rate, implantation rate and ongoing pregnancy and miscarriage rates in IVF and ICSI cycles. The three different embryo transfer media are: Hyaluronan-enriched medium Embryo Glue® 30% Protein-supplemented Culture medium Global Total® Autologous Follicular Fluid (a Novel technique) In order to establish the optimal media for embryo transfer

Detailed Description
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Two or three embryos will be transferred at day 5 after ovum pick-up (OPU). The patients will be divided randomly (closed envelop method) into 3 groups: Group A (50 patients): embryos will be transferred using a medium supplemented with 0.5 mg/mL of hyaluronic acid (EmbryoGlue®, Vitrolife, Sweden) for 20 minutes before intrauterine transfer took place Group B (50 patients): embryos will be transferred using a medium of 30% Protein-supplemented Culture Medium (Global total®, Life Global group, Canada) for 20 minutes. Group C (50 patients): a novel technique in which embryos will be transferred using a medium of autologous Follicular Fluid for 20 minutes. Follicular fluid will be collected in a sterile procedure, centrifuged for 20 minutes in an embryo test tube. The supernatant will be removed in a sterilized technique then heated to 56°C for 30 minutes then filtered through 0.22 micron filter. Gentamycin sulphate will be added at a concentration of 10 µg/mL then the liquid is preserved in a normal freezer. Defreezing follicular fluid will be performed at day-1 before embryo transfer. The follicular fluid will be warmed to room temperature. Preparation of embryo transfer media will be performed as usual, will be covered with paraffin oil (Ovoil®, Vitrolife, Sweeden) and then incubated overnight in 7% CO2, 9% O2, 22% N2. All embryo transfers will be performed using an embryo transfer catheter (Labotect catheter, Labotect GmbH, Germany). Number of embryos transferred will be according to ASRM guideline 2013 on day 5 after ovum pick-up (OPU).

Official Title
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Comparative Study Between Three Different Embryo Transfer Media: Hyaluronan-enriched Medium Embryo Glue®, 30% Protein-supplemented Culture Medium Global Total® and Autologous Follicular Fluid Concerning Chemical and Clinical Pregnancy Rate and Ongoing Pregnancy and Miscarriage Rates in ICSI Cycles

Conditions
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Improvement of Embryo Transfer Technique, Improvement of Implantation

Intervention / Treatment
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* Other: embryos will be transferred using a medium of 0.5 mg/mL of Hyaluronan-enriched medium (EmbryoGlue®, Vitrolife, Sweden)
* Other: embryos will be transferred using a medium of 30% Protein-supplemented Culture Medium (Global total®, Life Global group, Canada)
* Other: a novel technique in which embryos will be transferred using a medium of autologous Follicular Fluid
* Device: Labotect embryo transfer catheter


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age: 18-35 years Body mass index (BMI): ≤ 30 Anti-mullerian hormone (AMH): 1.1 - 3 No gynecological problem e.g. fibroid, endometriosis, uterine polyp, hydrosalpinx or adenomysis Male factor: mild to moderate oligo or asthenospermia Exclusion Criteria: Age: <18 years or >35 years Body mass index (BMI): >30 Anti-mullerian hormone (AMH): <1.1 or >3 gynecological problem e.g. fibroid, endometriosis, uterine polyp, hydrosalpinx or adenomysis will be excluded Male factor: Abnormal sperm morphology; (globozoospermia and pin-point sperm) and azoospermia; (whether obstructive or non-obstructive) will be excluded Patients with recurrent implantation failure

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Embryo Glue®<br>Hyaluronan-enriched medium | Other: embryos will be transferred using a medium of 0.5 mg/mL of Hyaluronan-enriched medium (EmbryoGlue®, Vitrolife, Sweden)<br> <br> Device: Labotect embryo transfer catheter<br> <br> |
| Active Comparator: Global Total®<br>30% Protein-supplemented Culture Medium | Other: embryos will be transferred using a medium of 30% Protein-supplemented Culture Medium (Global total®, Life Global group, Canada)<br> <br> Device: Labotect embryo transfer catheter<br> <br> |
| Experimental: Autologous Follicular Fluid<br>a novel technique | Other: a novel technique in which embryos will be transferred using a medium of autologous Follicular Fluid<br> <br> Device: Labotect embryo transfer catheter<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Chemical pregnancy rate | assessed by quantitative β hCG in the serum | 14 days after embryo transfer | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical pregnancy rate | assessed by ultrasonic visualization of intrauterine gestational sac | 6th week of gestation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Embryo transfer media, improvement of embryo transfer technique, improvement of implantation, Hyaluronan-enriched media Embryo Glue®, 30% Protein-supplemented Culture Medium Global Total®, Autologous Follicular Fluid as embryo transfer medium