Comparative Study of Three Different Embryo Transfer Media in ICSI Cycles

NCT ID: NCT02792673

Last Updated: 2016-06-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-31
• Study Completion Date: 2017-12-31

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).

Conditions

Improvement of Embryo Transfer Technique; Improvement of Implantation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: NONE

Study Groups

"Embryo Glue®"

Hyaluronan-enriched medium

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: OTHER

Labotect embryo transfer catheter

Intervention Type: DEVICE

"Global Total®"

30% Protein-supplemented Culture Medium

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: OTHER

Labotect embryo transfer catheter

Intervention Type: DEVICE

Autologous Follicular Fluid

a novel technique

Group Type: EXPERIMENTAL

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

Intervention Type: OTHER

Labotect embryo transfer catheter

Intervention Type: DEVICE

Interventions

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

Intervention Type: OTHER

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

Intervention Type: OTHER

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

Intervention Type: OTHER

Labotect embryo transfer catheter

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Ibn Sina Hospital

OTHER_GOV

Sponsor Role: collaborator

Qena Fertility Center, Qena, Egypt

UNKNOWN

Sponsor Role: collaborator

South Valley University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Mowafy

Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

Assisted Reproduction Unit - 1

Identifier Type: -

Identifier Source: org_study_id