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

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

Study Overview

• Status: Unknown
• Conditions: Improvement of Embryo Transfer Technique; Improvement of Implantation
• Intervention / 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; Other: embryos will be transferred using a medium of 30% Protein-supplemented Culture Medium (Global total®, Life Global group, Canada); Other: a novel technique in which embryos will be transferred using a medium of autologous Follicular Fluid

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).

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: "Embryo Glue®"; Hyaluronan-enriched medium	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
ACTIVE_COMPARATOR: "Global Total®"; 30% Protein-supplemented Culture Medium	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)
EXPERIMENTAL: Autologous Follicular Fluid; a novel technique	Device: Labotect embryo transfer catheter; Other: a novel technique in which embryos will be transferred using a medium of autologous Follicular Fluid

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Chemical pregnancy rate	assessed by quantitative β hCG in the serum	14 days after embryo transfer

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical pregnancy rate	assessed by ultrasonic visualization of intrauterine gestational sac	6th week of gestation

Other Outcome Measures

Outcome Measure	Time Frame
Implantation rate.	6th week of gestation
Ongoing pregnancy and miscarriage rates	12th week of gestation

Collaborators and Investigators

• Sponsor: South Valley University
• Collaborators: Ibn Sina Hospital; Qena Fertility Center, Qena, Egypt

Study record dates

Study Major Dates

• Study Start: May 1, 2016
• Primary Completion (ANTICIPATED): October 1, 2017
• Study Completion (ANTICIPATED): December 1, 2017

Study Registration Dates

• First Submitted: May 23, 2016
• First Submitted That Met QC Criteria: June 6, 2016
• First Posted (ESTIMATE): June 7, 2016

Study Record Updates

• Last Update Posted (ESTIMATE): June 7, 2016
• Last Update Submitted That Met QC Criteria: June 6, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• 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
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Immunologic Factors; Protective Agents; Adjuvants, Immunologic; Viscosupplements; Hyaluronic Acid
• Other Study ID Numbers: Assisted Reproduction Unit - 1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED