Improvement of Embryo Transfer TechniqueNCT02792673
Comparative Study of Three Different Embryo Transfer Media in ICSI Cycles
A study testing 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) and a novel technique in which embryos will be transferred using a medium of autologous Follicular Fluid in people with Improvement of Embryo Transfer Technique and Improvement of Implantation, run by South Valley University.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Improvement of Embryo Transfer Technique, Improvement of Implantation
- What is being tested?
- 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) and a novel technique in which embryos will be transferred using a medium of autologous Follicular Fluid
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- May 2016to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age: 18-35 years
- Body mass index (BMI): ≤ 30
- Anti-mullerian hormone (AMH): 1.1 - 3
- No gynecological problem e.g. fibroid, endometriosis, uterine polyp, hydrosalpinx or adenomysis
- Male factor: mild to moderate oligo or asthenospermia
Who cannot join
- Age: <18 years or >35 years
- Body mass index (BMI): >30
- Anti-mullerian hormone (AMH): <1.1 or >3
- gynecological problem e.g. fibroid, endometriosis, uterine polyp, hydrosalpinx or adenomysis will be excluded
- Male factor: Abnormal sperm morphology; (globozoospermia and pin-point sperm) and azoospermia; (whether obstructive or non-obstructive) will be excluded
- Patients with recurrent implantation failure
About this study
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
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:
- Hyaluronan-enriched medium "Embryo Glue®"
- 30% Protein-supplemented Culture medium "Global Total®"
- 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).
- Being tested
- 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
- 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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
embryos will be transferred using a medium of 0.5 mg/mL of Hyaluronan-enriched medium (EmbryoGlue®, Vitrolife, Sweden)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 FluidOther
Labotect embryo transfer catheterDevice
| Study group | Role | What they receive |
|---|---|---|
| "Embryo Glue®" | Active comparator | Hyaluronan-enriched medium Receives: 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 |
| "Global Total®" | Active comparator | 30% Protein-supplemented Culture Medium Receives: 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 |
| Autologous Follicular Fluid | Experimental | a novel technique Receives: Other: a novel technique in which embryos will be transferred using a medium of autologous Follicular Fluid; Device: Labotect embryo transfer catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chemical pregnancy rate
assessed by quantitative β hCG in the serum
Measured: 14 days after embryo transfer
Secondary outcomes (1)
Clinical pregnancy rate
assessed by ultrasonic visualization of intrauterine gestational sac
Measured: 6th week of gestation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2016 (estimated)
- Study startMay 2016
- Primary completionOct 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Improvement of Embryo Transfer TechniqueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- South Valley University
- Sponsor type
- University, hospital or other
- Collaborators
- Ibn Sina Hospital, Qena Fertility Center, Qena, Egypt
- Responsible party
- Principal investigator, Ahmed Mowafy, South Valley University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02792673
- Sponsor's protocol ID
- Assisted Reproduction Unit - 1
- Status last verified
- Jun 2016
- First submitted
- 23 May 2016
- Last updated
- 7 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02792673
- Acronym / sponsor ID
- Assisted Reproduction Unit - 1
- 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
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- South Valley UniversityUniversity, hospital or other
- Collaborators
- Ibn Sina Hospital, Qena Fertility Center, Qena, Egypt
- Study start
- May 2016
- Primary completion
- Oct 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 7 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Hyaluronan-enriched medium "Embryo Glue®"
- 30% Protein-supplemented Culture medium "Global Total®"
- 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 design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| "Embryo Glue®" | Active comparator | Other: embryos will be transferred using a medium of 0.5 mg/mL of Hyaluronan-enriched medium (EmbryoGlue®, Vitrolife, Sweden), Device: Labotect embryo transfer catheterHyaluronan-enriched medium |
| "Global Total®" | Active comparator | Other: embryos will be transferred using a medium of 30% Protein-supplemented Culture Medium (Global total®, Life Global group, Canada), Device: Labotect embryo transfer catheter30% Protein-supplemented Culture Medium |
| Autologous Follicular Fluid | Experimental | Other: a novel technique in which embryos will be transferred using a medium of autologous Follicular Fluid, Device: Labotect embryo transfer cathetera novel technique |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age: 18-35 years
- Body mass index (BMI): ≤ 30
- Anti-mullerian hormone (AMH): 1.1 - 3
- No gynecological problem e.g. fibroid, endometriosis, uterine polyp, hydrosalpinx or adenomysis
- Male factor: mild to moderate oligo or asthenospermia
Key exclusion criteria (6 listed)
- Age: <18 years or >35 years
- Body mass index (BMI): >30
- Anti-mullerian hormone (AMH): <1.1 or >3
- gynecological problem e.g. fibroid, endometriosis, uterine polyp, hydrosalpinx or adenomysis will be excluded
- Male factor: Abnormal sperm morphology; (globozoospermia and pin-point sperm) and azoospermia; (whether obstructive or non-obstructive) will be excluded
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| embryos will be transferred using a medium of 0.5 mg/mL of Hyaluronan-enriched medium (EmbryoGlue®, Vitrolife, Sweden) | Other | "Embryo Glue®" |
| embryos will be transferred using a medium of 30% Protein-supplemented Culture Medium (Global total®, Life Global group, Canada) | Other | "Global Total®" |
| a novel technique in which embryos will be transferred using a medium of autologous Follicular Fluid | Other | Autologous Follicular Fluid |
| Labotect embryo transfer catheter | Device | "Embryo Glue®", "Global Total®", Autologous Follicular Fluid |
Primary outcome
Chemical pregnancy rate
Time frame: 14 days after embryo transfer
assessed by quantitative β hCG in the serum
1 secondary outcome
Clinical pregnancy rate
Time frame: 6th week of gestation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2016.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing 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) and a novel technique in which embryos will be transferred using a medium of autologous Follicular Fluid in people with Improvement of Embryo Transfer Technique and Improvement of Implantation, run by South Valley University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chemical pregnancy rate (time frame: 14 days after embryo transfer). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2016.