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
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- South Valley University
- Enrollment
- 150
- Primary Endpoint
- Chemical pregnancy rate
Study Overview
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:
- 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
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 35 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
"Embryo Glue®"
Hyaluronan-enriched medium
Intervention: embryos will be transferred using a medium of 0.5 mg/mL of Hyaluronan-enriched medium (EmbryoGlue®, Vitrolife, Sweden) (Other)
"Embryo Glue®"
Hyaluronan-enriched medium
Intervention: Labotect embryo transfer catheter (Device)
"Global Total®"
30% Protein-supplemented Culture Medium
Intervention: embryos will be transferred using a medium of 30% Protein-supplemented Culture Medium (Global total®, Life Global group, Canada) (Other)
"Global Total®"
30% Protein-supplemented Culture Medium
Intervention: Labotect embryo transfer catheter (Device)
Autologous Follicular Fluid
a novel technique
Intervention: a novel technique in which embryos will be transferred using a medium of autologous Follicular Fluid (Other)
Autologous Follicular Fluid
a novel technique
Intervention: Labotect embryo transfer catheter (Device)
Outcomes
Primary Outcomes
Chemical pregnancy rate
Time Frame: 14 days after embryo transfer
assessed by quantitative β hCG in the serum
Secondary Outcomes
- Clinical pregnancy rate(6th week of gestation)
Investigators
Ahmed Mowafy
Investigator
South Valley University