Comparative Study of Three Different Embryo Transfer Media in ICSI Cycles

South Valley University

Status: Unknown

Conditions: Improvement of Implantation; Improvement of Embryo Transfer Technique

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

Study type: Interventional

Funder types: Other

Identifiers

NCT02792673

Assisted Reproduction Unit - 1

Details and patient eligibility

About

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

Full 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).

Enrollment: 150 estimated patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

150 participants in 3 patient groups

"Embryo Glue®"

Active Comparator group

Description:

Hyaluronan-enriched medium

Treatment:

Other: embryos will be transferred using a medium of 0.5 mg/mL of Hyaluronan-enriched medium (EmbryoGlue®, Vitrolife, Sweden)

Device: Labotect embryo transfer catheter

"Global Total®"

Active Comparator group

Description:

30% Protein-supplemented Culture Medium

Treatment:

Device: Labotect embryo transfer catheter

Other: embryos will be transferred using a medium of 30% Protein-supplemented Culture Medium (Global total®, Life Global group, Canada)

Autologous Follicular Fluid

Experimental group

Description:

a novel technique

Treatment:

Other: a novel technique in which embryos will be transferred using a medium of autologous Follicular Fluid

Device: Labotect embryo transfer catheter