- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02725827
Hyaluronan-enriched Embryo Transfer Medium for Frozen-thawed Embryo Transfer
Randomized Controlled Trial Comparing Hyaluronan-enriched Embryo Transfer Medium Versus Control for Frozen-thawed Embryo Transfer
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Women being scheduled for FET will be assessed for eligibility. Eligible women will be recruited for the study and each woman will only be included in the study with one FET cycle. Informed written consent will be obtained. Their baseline characteristics will be collected.
Women with regular ovulatory cycles will undergo the standard procedures of blood taking to identify the day of luteinizing hormone (LH) surge. Women with irregular cycles will either receive clomiphene or letrozole followed by detection of the LH surge, or undergo hormone replacement therapy (HRT) cycle with oral oestradiol 6 mg daily for 14 days for endometrial priming followed by the addition of vaginal micronized progesterone 100 mg three times daily. HRT cycle may also be used for scheduling purposes.
Embryo transfer will be performed 3 or 4 days (for cleavage-stage embryos) or 6 or 7 days (for blastocysts) after the LH surge. For women in HRT cycles, FET will be scheduled on the 4th or 5th day (for cleavage-stage embryos) or the 7th or 8th day (for blastocysts) of starting vaginal progesterone. They will continue oral oestradiol and vaginal progesterone after FET up to 12 weeks of gestation.
Randomization:
One day before scheduled FET, recruited women will be randomized into one of the following two groups: (1) HA group and (2) control group according to a computer-generated randomization list prepared by a designated research nurse.
One the day of FET, frozen embryos or blastocysts will be thawed and incubated for at least 10 minutes in embryo transfer medium. For women allocated to the HA group, EmbryoGlue (Vitrolife) will be used as embryo transfer medium, while in the control group the usual medium used in the study center will used. The main difference between the two media is that EmbryoGlue contains a higher concentration of HA.
The rest of the embryo transfer procedure will be the same as the usual practice.
Blinding:
The patient and the physicians performing the FET and involved in her care will not know the group allocation. Only the embryologist will know the group allocation, but they will not be involved in the patient care, the FET procedure and subsequent assessment.
Follow-up and data collection:
A urine pregnancy test is performed 18 days after the LH surge or starting vaginal progesterone. If the pregnancy test is positive, transvaginal ultrasound will be performed 2 weeks later to locate the pregnancy and fetal viability. Subsequent management will be the same as other women with early pregnancy. They will be referred for antenatal care when the pregnancy is on-going at 8 weeks.
Follow-up:
Written consent regarding retrieval of pregnancy and delivery data from both public and private sectors will be sought from the patient at the time of study. The obstetric outcomes will be traced from the electric patient record system if the patients deliver in Hospital Authority hospitals. A pre-formatted letter with replying address available will be given to the patient at the end of the study period and is to be filled by the private obstetrician and returned to us after delivery. If no reply letter is received 2-3 months after the expected date of confinement of the patient, a letter including patient's authorization will be sent to the corresponding private obstetrician to retrieve the information of the pregnancy outcomes. The outcome of the pregnancy (delivery, miscarriage), number of babies born, birth weights and obstetrics complications will be recorded.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Hong Kong, Hong Kong
- Kwong Wah Hospital
-
Hong Kong, Hong Kong
- Queen Mary Hospital, University of Hong Kong
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Women panning to replacing early cleavage embryos or blastocysts after thawing.
Exclusion Criteria:
- Frozen early cleavage embryos thawed and cultured to blastocysts prior to transfer as requested by the patient
- Preimplantation genetic diagnosis treatment
- Use of donor oocytes or donor embryos
- Endometrial thickness <8mm on the day of the luteinizing hormone surge or after two weeks of estrogen in hormonal replacement cycles
- Hydrosalpinx shown on pelvic scanning and not surgically treated
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: HA group
One the day of frozen-thawed embryo transfer, frozen embryos will be thawed and incubated for at least 10 minutes in embryo transfer medium.
For women allocated to the HA group, EmbryoGlue (Vitrolife), a hyaluronan-enriched embryo transfer medium, will be used as embryo transfer medium.
EmbryoGlue contains a higher concentration of hyaluronan than the control medium.
|
A hyaluronan-enriched embryo transfer medium
|
Active Comparator: Control group
For women allocated to the control group, the usual transfer medium used in the study centers will be used and will serve as control.
The main difference between the two media is that EmbryoGlue contains a higher concentration of HA.
|
The usual embryo transfer medium used in the study centres.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Live-birth rate per embryo transfer procedure
Time Frame: 1 year
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
pregnancy rate
Time Frame: 4 weeks
|
positive urine pregnancy test
|
4 weeks
|
clinical pregnancy rate
Time Frame: 4 weeks
|
presence of intrauterine gestational sac on ultrasound
|
4 weeks
|
implantation rate
Time Frame: 8 weeks
|
number of gestational sacs per embryo transferred
|
8 weeks
|
on-going pregnancy rate
Time Frame: 8 weeks
|
viable pregnancy beyond gestation 8 weeks
|
8 weeks
|
adverse events
Time Frame: 12 weeks
|
12 weeks
|
|
obstetric complications
Time Frame: 1 year
|
1 year
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Shuk Fei Sofie Yung, MBBS, The University of Hong Kong
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UW 16-158
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on In Vitro Fertilization
-
Mỹ Đức HospitalVrije Universiteit BrusselNot yet recruiting
-
Heilongjiang University of Chinese MedicineNot yet recruitingIn Vitro FertilizationChina
-
Organon and CoCompleted
-
Kanuni Sultan Suleyman Training and Research HospitalCompleted
-
Rambam Health Care CampusUnknownFertilization in Vitro
-
IBSA Institut Biochimique SACompletedIn Vitro FertilizationItaly, United Kingdom, Germany, Hungary, Switzerland
-
Bahceci Health GroupUnknownIn-vitro FertilizationTurkey
-
Mỹ Đức HospitalRecruitingin Vitro FertilizationVietnam
Clinical Trials on EmbryoGlue (Vitrolife)
-
University Hospital, GhentRecruitingMiscarriage, Recurrent | IVF | Embryo LossBelgium
-
University of OxfordOxford Fertility Limited, United KingdomUnknown
-
University Hospital, Clermont-FerrandVitrolifeUnknown
-
Mayo ClinicTerminatedInfertility | Embryo ImplantationUnited States
-
ART Fertility Clinics LLCRecruitingInfertility | Live Birth Rate | Clinical Pregnancy Rate | Implantation Rate | FET | BlastocystsUnited Arab Emirates
-
University Hospital, Clermont-FerrandRecruitingFertility | Assisted Reproductive Technology | Vitrification | Egg DonorFrance
-
University Hospital, GhentCompleted
-
Weill Medical College of Cornell UniversityVitrolifeTerminatedInfertilityUnited States
-
Erasme University HospitalCompletedHuman Embryo CryopreservationBelgium
-
South Valley UniversityIbn Sina Hospital; Qena Fertility Center, Qena, EgyptUnknownImprovement of Embryo Transfer Technique | Improvement of Implantation