Comparative Study of Three Different Embryo Transfer Media in ICSI Cycles

Not Applicable

• Conditions: Improvement of Embryo Transfer Technique; Improvement of Implantation
• Interventions: Other: embryos will be transferred using a medium of 30% Protein-supplemented Culture Medium (Global total®, Life Global group, Canada); 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

• Registration Number: NCT02792673
• Lead Sponsor: South Valley University

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).

Study Timeline

• Study Start: 2016-05
• Study First Submitted: 2016-05-23
• Status Verified: 2016-06
• Study First Submitted QC: 2016-06-06
• Last Update Submitted: 2016-06-06
• Study First Posted: 2016-06-07
• Last Update Posted: 2016-06-07
• Primary Completion: 2017-10
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 150

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
"Global Total®"	embryos will be transferred using a medium of 30% Protein-supplemented Culture Medium (Global total®, Life Global group, Canada)	30% Protein-supplemented Culture Medium
"Global Total®"	Labotect embryo transfer catheter	30% Protein-supplemented Culture Medium
"Embryo Glue®"	Labotect embryo transfer catheter	Hyaluronan-enriched medium
"Embryo Glue®"	embryos will be transferred using a medium of 0.5 mg/mL of Hyaluronan-enriched medium (EmbryoGlue®, Vitrolife, Sweden)	Hyaluronan-enriched medium
Autologous Follicular Fluid	a novel technique in which embryos will be transferred using a medium of autologous Follicular Fluid	a novel technique
Autologous Follicular Fluid	Labotect embryo transfer catheter	a novel technique

Primary Outcome Measures

Name	Time	Method
Chemical pregnancy rate	14 days after embryo transfer	assessed by quantitative β hCG in the serum

Secondary Outcome Measures

Name	Time	Method
Clinical pregnancy rate	6th week of gestation	assessed by ultrasonic visualization of intrauterine gestational sac