Clinical trial NCT02792673: Comparative Study of Three Different Embryo Transfer Media in ICSI Cycles
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Improvement of Embryo Transfer Technique
Improvement of Implantation
Keywords: 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
Lead sponsor: South Valley University
Sponsor class: OTHER
Collaborators: name: Ibn Sina Hospital
name: Qena Fertility Center, Qena, Egypt
First posted: 2016-06-07
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: 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:

1. Hyaluronan-enriched medium "Embryo Glue®"
2. 30% Protein-supplemented Culture medium "Global Total®"
3. Autologous Follicular Fluid (a Novel technique) In order to establish the optimal media for embryo transfer

Detailed description: 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).

Eligibility criteria: Inclusion Criteria:

1. Age: 18-35 years
2. Body mass index (BMI): ≤ 30
3. Anti-mullerian hormone (AMH): 1.1 - 3
4. No gynecological problem e.g. fibroid, endometriosis, uterine polyp, hydrosalpinx or adenomysis
5. Male factor: mild to moderate oligo or asthenospermia

Exclusion Criteria:

1. Age: \<18 years or \>35 years
2. Body mass index (BMI): \>30
3. Anti-mullerian hormone (AMH): \<1.1 or \>3
4. gynecological problem e.g. fibroid, endometriosis, uterine polyp, hydrosalpinx or adenomysis will be excluded
5. Male factor: Abnormal sperm morphology; (globozoospermia and pin-point sperm) and azoospermia; (whether obstructive or non-obstructive) will be excluded
6. Patients with recurrent implantation failure

Primary outcomes:
measure: Chemical pregnancy rate
timeFrame: 14 days after embryo transfer
Secondary outcomes:
measure: Clinical pregnancy rate
timeFrame: 6th week of gestation
Other outcomes:
measure: Implantation rate.
timeFrame: 6th week of gestation
measure: Ongoing pregnancy and miscarriage rates
timeFrame: 12th week of gestation
Locations:
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