Overview

This trial is active, not recruiting.

Conditions improvement of embryo transfer technique, improvement of implantation
Treatments embryos will be transferred using a medium of 0.5 mg/ml of hyaluronan-enriched medium (embryoglue®, vitrolife, sweden), embryos will be transferred using a medium of 30% protein-supplemented culture medium (global total®, life global group, canada), a novel technique in which embryos will be transferred using a medium of autologous follicular fluid, labotect embryo transfer catheter
Sponsor South Valley University
Collaborator Ibn Sina Hospital
Start date May 2016
End date October 2017
Trial size 150 participants
Trial identifier NCT02792673, Assisted Reproduction Unit - 1

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Arm
(Active Comparator)
Hyaluronan-enriched medium
embryos will be transferred using a medium of 0.5 mg/ml of hyaluronan-enriched medium (embryoglue®, vitrolife, sweden)
labotect embryo transfer catheter
(Active Comparator)
30% Protein-supplemented Culture Medium
embryos will be transferred using a medium of 30% protein-supplemented culture medium (global total®, life global group, canada)
labotect embryo transfer catheter
(Experimental)
a novel technique
a novel technique in which embryos will be transferred using a medium of autologous follicular fluid
labotect embryo transfer catheter

Primary Outcomes

Measure
Chemical pregnancy rate
time frame: 14 days after embryo transfer

Secondary Outcomes

Measure
Clinical pregnancy rate
time frame: 6th week of gestation

Eligibility Criteria

Female participants from 18 years up to 35 years old.

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

Additional Information

Official title 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
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).
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by South Valley University.