CClinicalTrials.gg
Status unknownNCT02792673Updated Jun 7, 2016

Comparative Study of Three Different Embryo Transfer Media in ICSI Cycles

An interventional study of embryos will be transferred using a medium of 0.5 mg/mL of Hyaluronan-enriched medium (EmbryoGlue®, Vitrolife, Sweden) and embryos will be transferred using a medium of 30% Protein-supplemented Culture Medium (Global total®, Life Global group, Canada) in Improvement of Embryo Transfer Technique and Improvement of Implantation, sponsored by South Valley University. Status unknown. Open to female participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-06-07.

Sponsored by South Valley University · Not applicable and Interventional

The sponsor has not verified this record recently (last verified Jun 2016), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
150
Allocation
Randomized
Ages
18 Years to 35 Years
Sex
Female
01

Study 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
Read the 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).

02

Conditions studied

  • Improvement of Embryo Transfer Technique
  • Improvement of Implantation

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
03

In context

Lead sponsor

South Valley University is the lead sponsor of 147 studies on the registry; 46 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 35 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
150 participants (estimated)

Study arms

  • 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

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

  • Experimental
    Autologous Follicular Fluid

    a novel technique

    Other: a novel technique in which embryos will be transferred using a medium of autologous Follicular Fluid · Device: Labotect embryo transfer catheter

Interventions

  • Otherembryos will be transferred using a medium of 0.5 mg/mL of Hyaluronan-enriched medium (EmbryoGlue®, Vitrolife, Sweden)
  • Otherembryos will be transferred using a medium of 30% Protein-supplemented Culture Medium (Global total®, Life Global group, Canada)
  • Othera novel technique in which embryos will be transferred using a medium of autologous Follicular Fluid
  • DeviceLabotect embryo transfer catheter
06

What researchers measure

Primary outcomes

  1. Chemical pregnancy rate

    assessed by quantitative β hCG in the serum

    Time frame: 14 days after embryo transfer

Secondary outcomes

  1. Clinical pregnancy rate

    assessed by ultrasonic visualization of intrauterine gestational sac

    Time frame: 6th week of gestation

Other outcomes

  1. Implantation rate.

    Time frame: 6th week of gestation

  2. Ongoing pregnancy and miscarriage rates

    Time frame: 12th week of gestation

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 7, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02792673
Lead sponsor
South Valley University
Collaborators
Ibn Sina Hospital, Qena Fertility Center, Qena, Egypt
Responsible party
Ahmed Mowafy (Investigator, South Valley University) — Principal investigator
First posted
Jun 7, 2016
Start date
May 2016
Primary completion
Oct 2017 (estimated)
Completion
Dec 2017 (estimated)
Last update
Jun 7, 2016

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2016. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion