InfertilityNCT02987075
A Comparison of Ongoing Pregnancy Rate Between Cleavage Stage and Early Compacting Embryo Transfer at 66±2 Hours After ICSI Using Single Step Culture Medium
A study testing Compacting embryo transferring and Non- compacting embryo transferring in people with Infertility, run by Vietnam National University at 1 site in Vietnam.
Trial summary
A comparison of ongoing pregnancy rate between cleavage stage and early compacting embryo transfer at 66±2 hours after ICSI using single step culture medium Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Infertility
- What is being tested?
- Compacting embryo transferring and Non- compacting embryo transferring
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 430 participants
- Where
- 1 siteVietnam
- Study dates
- Dec 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- IVF treatment for infertility
- Controlled ovarian hyperstimulation by GnRH antagonist protocol.
- IVF cycles ≤2
- Eligible for transfer of 2 embryos on day 3
- Have at least 2 embryos which are 7-9 cells and fragmentation ≤20%, that had either early compaction or still on cleavage stage
Who cannot join
- Oocyte donation cycles
- Abnormal uterine
- Using GnRH agonist for triggering.
Trial locations and contacts
1 site in 1 country.
Vietnam1 site, 1 recruiting
- Recruiting
My Duc Hospital
Ho Chi Minh City, 70000
Vinh Q Dang, MD, +84908225481, bsvinh.dq@myduchospital.vn
Bao G Huynh, MSc, + 84 908609348, bao.hg@myduchospital.vn
About this study
A comparison of ongoing pregnancy rate between cleavage stage and early compacting embryo transfer at 66±2 hours after ICSI using single step culture medium
Read the detailed description
A prospective cohort study to compare the outcomes of transferring the early compacting and the cleavage day 3 embryos.
All participants were treated with a gonadotropin-releasing antagonist protocol according to local protocol. Recombinant follicle stimulating hormone was given for five days starting on the second or third day of the menstrual cycle at a starting dose individualized for each participant as follows: 150, 225 or 300 IU/day, respectively, in participants with anti-Müllerian hormone levels of <2.1 ng/mL, 0.7-2.1 ng/mL or <0.7 ng/mL. This dosage could then be titrated based on clinical judgement of the investigator. Follicular development was monitored using ultrasound scanning and measurement of estradiol and progesterone levels, starting on day five of stimulation; scanning and hormonal measurements were repeated every two to three days, depending on follicle size. An antagonist was routinely used on day five until the day of human chorionic gonadotropin administration. Criteria for administration of recombinant human chorionic gonadotropin (5,000 IU) was the presence of at least two leading follicles of 17 mm in diameter. Oocyte retrieval was performed 36 hours after recombinant human chorionic gonadotropin administration.
Insemination was performed using intra-cytoplasmic sperm injection at three to four hours after oocyte retrieval; only matured oocytes were inseminated. Fertilization check was performed under inverted microscope at 16-18 hours after insemination. Embryo evaluation was performed on day 3 at fixed time point after fertilization (66±2 hours) using the Istanbul consensus. As a rule, two useful embryos are transferred in patients if having either early compaction or still on cleavage stage.
Early compaction embryo transfer group: transfer of 2 utilizable compacting embryos.
Cleavage stage embryo transfer group: transfer of 2 utilizable non-compacting embryos have 7-9 cells with under 20% fragmentation.
Embryo transfer was performed using a soft catheter by a standard technique under ultrasound guidance. Intensive luteal phase support was provided using progesterone gel and estradiol. At least 18 days after OPU, a urinary pregnancy test is performed. If the pregnancy test is positive, vaginal and/or abdominal ultrasonographic investigation is performed between 35 and 42 days (5 to 6 weeks) after ET to confirm a clinical pregnancy and at least 70 days (≥10 weeks) after ET to confirm an ongoing pregnancy.
Other clinical parameters will also be evaluated: serum hormone levels, fertilization rate, number and quality of day 3 embryos, implantation rate, ectopic pregnancy rate and miscarriage rate.
- Conditions
- Infertility
- Being tested
- Compacting embryo transferring, Non- compacting embryo transferring
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Compacting embryo transferringOther
transfer of 2 utilizable compacting embryos
Non- compacting embryo transferringOther
transfer of 2 utilizable non-compacting embryos have 7-9 cells with under 20% fragmentation.
| Study group | Role | What they receive |
|---|---|---|
| Early compaction embryo group | Other | patients have compacting embryos at 66±2 hours after ICSI Receives: Other: Compacting embryo transferring |
| Cleavage stage embryo group | Other | patients have non-compacting embryos with 7-9 cells, under 20% fragmentation. at 66±2 hours after ICSI Receives: Other: Non- compacting embryo transferring |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome measure was ongoing pregnancy rate, defined as a pregnancy with a detectable heart rate at 12 weeks of gestation or beyond.
Measured: 12 weeks
Secondary outcomes (4)
Clinical pregnancy rate, defined as the presence of a gestational sac under ultrasonography
Measured: 7 weeks
Implantation rate (number of gestational sacs on ultrasound at 7 weeks / total number of embryos transferred x 100).
Measured: 7 weeks
Ectopic pregnancy rate, defined as the ectopic nidation of a pregnancy, confirmed with sonography or laparoscopy
Measured: 7 weeks
Miscarriage rate, defined as the loss of a pregnancy prior to 12 weeks gestation
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2016 (estimated)
- Study startDec 2016
- Primary completionNov 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 InfertilityStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 430 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vietnam National University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manh Tuong Ho, Vietnam National University
- Investigators
- Tuong M Ho, MD, Principal investigator, CGRH - Vietnam National University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02987075
- Sponsor's protocol ID
- NCKH-08-2016
- Status last verified
- Jul 2017
- First submitted
- 25 Nov 2016
- Last updated
- 17 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Ongoing Pregnancy Rate Between Cleavage Stage and Early Compacting Embryo Transfer at 66±2 Hours After ICSI Using Single Step Culture Medium
- ClinicalTrials.gov ID
- NCT02987075
- Acronym / sponsor ID
- NCKH-08-2016
- Conditions
- Infertility
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 430 participants (estimated)
- Lead sponsor
- Vietnam National UniversityUniversity, hospital or other
- Study start
- Dec 2016
- Primary completion
- Nov 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 8 Dec 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.
A comparison of ongoing pregnancy rate between cleavage stage and early compacting embryo transfer at 66±2 hours after ICSI using single step culture medium
Detailed description
A prospective cohort study to compare the outcomes of transferring the early compacting and the cleavage day 3 embryos.
All participants were treated with a gonadotropin-releasing antagonist protocol according to local protocol. Recombinant follicle stimulating hormone was given for five days starting on the second or third day of the menstrual cycle at a starting dose individualized for each participant as follows: 150, 225 or 300 IU/day, respectively, in participants with anti-Müllerian hormone levels of <2.1 ng/mL, 0.7-2.1 ng/mL or <0.7 ng/mL. This dosage could then be titrated based on clinical judgement of the investigator. Follicular development was monitored using ultrasound scanning and measurement of estradiol and progesterone levels, starting on day five of stimulation; scanning and hormonal measurements were repeated every two to three days, depending on follicle size. An antagonist was routinely used on day five until the day of human chorionic gonadotropin administration. Criteria for administration of recombinant human chorionic gonadotropin (5,000 IU) was the presence of at least two leading follicles of 17 mm in diameter. Oocyte retrieval was performed 36 hours after recombinant human chorionic gonadotropin administration.
Insemination was performed using intra-cytoplasmic sperm injection at three to four hours after oocyte retrieval; only matured oocytes were inseminated. Fertilization check was performed under inverted microscope at 16-18 hours after insemination. Embryo evaluation was performed on day 3 at fixed time point after fertilization (66±2 hours) using the Istanbul consensus. As a rule, two useful embryos are transferred in patients if having either early compaction or still on cleavage stage.
Early compaction embryo transfer group: transfer of 2 utilizable compacting embryos.
Cleavage stage embryo transfer group: transfer of 2 utilizable non-compacting embryos have 7-9 cells with under 20% fragmentation.
Embryo transfer was performed using a soft catheter by a standard technique under ultrasound guidance. Intensive luteal phase support was provided using progesterone gel and estradiol. At least 18 days after OPU, a urinary pregnancy test is performed. If the pregnancy test is positive, vaginal and/or abdominal ultrasonographic investigation is performed between 35 and 42 days (5 to 6 weeks) after ET to confirm a clinical pregnancy and at least 70 days (≥10 weeks) after ET to confirm an ongoing pregnancy.
Other clinical parameters will also be evaluated: serum hormone levels, fertilization rate, number and quality of day 3 embryos, implantation rate, ectopic pregnancy rate and miscarriage rate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early compaction embryo group | Other | Other: Compacting embryo transferringpatients have compacting embryos at 66±2 hours after ICSI |
| Cleavage stage embryo group | Other | Other: Non- compacting embryo transferringpatients have non-compacting embryos with 7-9 cells, under 20% fragmentation. at 66±2 hours after ICSI |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- IVF treatment for infertility
- Controlled ovarian hyperstimulation by GnRH antagonist protocol.
- IVF cycles ≤2
- Eligible for transfer of 2 embryos on day 3
- Have at least 2 embryos which are 7-9 cells and fragmentation ≤20%, that had either early compaction or still on cleavage stage
Key exclusion criteria (3 listed)
- Oocyte donation cycles
- Abnormal uterine
- Using GnRH agonist for triggering.
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 |
|---|---|---|
| Compacting embryo transferringtransfer of 2 utilizable compacting embryos | Other | Early compaction embryo group |
| Non- compacting embryo transferringtransfer of 2 utilizable non-compacting embryos have 7-9 cells with under 20% fragmentation. | Other | Cleavage stage embryo group |
Primary outcome
The primary outcome measure was ongoing pregnancy rate, defined as a pregnancy with a detectable heart rate at 12 weeks of gestation or beyond.
Time frame: 12 weeks
4 secondary outcomes
Clinical pregnancy rate, defined as the presence of a gestational sac under ultrasonography
Time frame: 7 weeks
Implantation rate (number of gestational sacs on ultrasound at 7 weeks / total number of embryos transferred x 100).
Time frame: 7 weeks
Ectopic pregnancy rate, defined as the ectopic nidation of a pregnancy, confirmed with sonography or laparoscopy
Time frame: 7 weeks
Miscarriage rate, defined as the loss of a pregnancy prior to 12 weeks gestation
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2017.
- Individual participant dataSharing planned: No
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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.
Tuong M Ho, MD principal investigator
CGRH - Vietnam National University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Compacting embryo transferring and Non- compacting embryo transferring in people with Infertility, run by Vietnam National University at 1 site in Vietnam.
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 3 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 17 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Contact Tuong M Ho, MD (+84 906633377, homanhtuong@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome measure was ongoing pregnancy rate, defined as a pregnancy with a detectable heart rate at 12 weeks of gestation or beyond. (time frame: 12 weeks). 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 17 Jul 2017.