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Comparative Study of Three Different Embryo Transfer Media in ICSI Cycles

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02792673
Enrollment
150
Registered
2016-06-07
Start date
2016-05-31
Completion date
2017-12-31
Last updated
2016-06-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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).

Interventions

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

Sponsors

Ibn Sina Hospital
CollaboratorOTHER_GOV
Qena Fertility Center, Qena, Egypt
CollaboratorUNKNOWN
South Valley University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Chemical pregnancy rate14 days after embryo transferassessed by quantitative β hCG in the serum

Secondary

MeasureTime frameDescription
Clinical pregnancy rate6th week of gestationassessed by ultrasonic visualization of intrauterine gestational sac

Other

MeasureTime frame
Implantation rate.6th week of gestation
Ongoing pregnancy and miscarriage rates12th week of gestation

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026