InfertilityNCT03823235
Humidified Culture and Live Birth After ICSI
A study testing Human embryo culture in people with Infertility, run by Ibn Sina Hospital at 3 sites in Egypt.
Trial summary
Humidity for human embryo culture has been raised as essential with advantageous effect on clinical pregnancy and ongoing pregnancy after ICSI compared with a dry incubator. Whether the deleterious effect of dry culture would have an extended effect reaches the live birth rate needs to be examined. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- Human embryo culture
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,837 participants
- Where
- 3 sitesEgypt
- Study dates
- 1 Feb 2019to 27 Mar 2020
- 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 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women undergoing a first or second ICSI attempts
- Primary or secondary infertility with a BMI of < 31 kg/m2
- Duration of infertility of ≥ 18 months and normal baseline ultrasonography
- 18 to 40 years of age
- Tubal factor, male factor, polycystic ovary, unexplained infertility or combined factors
- Tubal factors
Who cannot join
- Surgically-retrieved, frozen-thawed and pinpoint sperm or globozoospermia
- Thin endometrium
- Uterine anomaly and adhesion
- Adenomyosis
- Submucous myoma
- Endometriosis
- Severe medical condition
Trial locations and contacts
3 sites in 1 country.
Egypt3 sites
Banon Assiut
Asyut
Qena Fertility Center
Qina, Qena Governorate, 123456
IbnSina IVF Center
Sohag
About this study
Official title: Humidified Incubator Effect on Live Birth Rate After ICSI
Humidity for human embryo culture has been raised as essential with advantageous effect on clinical pregnancy and ongoing pregnancy after ICSI compared with a dry incubator. Whether the deleterious effect of dry culture would have an extended effect reaches the live birth rate needs to be examined. This RCT is to examine the effect of dry and humidified culture on live birth rates after ICSI.
- Conditions
- Infertility
- Being tested
- Human embryo culture
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Human embryo cultureOther
humidifed or dry incubator
| Study group | Role | What they receive |
|---|---|---|
| Culture of human embryo in non-humidified incubator | Experimental | Embryo culture after in vitro fertilization in incubator with no humidity Receives: Other: Human embryo culture |
| Culture of human embryo in humidified incubator | No intervention | Embryo culture after in vitro fertilization in incubator with humidity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Live birth rate
Viable neonate after 30 weeks of gestation per initiated cycle
Measured: 30 weeks
Secondary outcomes (18)
Cumulative live birth rate
Viable neonate after 30 weeks of gestation after one fresh and/or one frozen-warmed transfer per initiated cycle
Measured: One year
Ongoing pregnancy rate
Continued pregnancy after 12 weeks of gestation per initiated cycle
Measured: 12 weeks of gestation
Cumulative ongoing pregnancy rate
Continued pregnancy after 12 weeks of gestation per initiated cycle within one year of randomization
Measured: 12 weeks of gestation
Clinical pregnancy rate
Ultrasound detect heartbeat after 7 weeks of gestation per initiated cycle
Measured: 7 weeks of gestation
Cumulative clinical pregnancy rate
Ultrasound detect heartbeat after 7 weeks of gestation per initiated cycle within one year of randomization
Measured: 7 weeks of gestation
Implantation rate
Number of sacs with a heartbeat per number of embryo transferred
Measured: 7 weeks of gestation
Cumulative implantation rate
Number of sacs with a heartbeat per number of embryo transferred within one year of randomization
Measured: 7 weeks of gestation
Ongoing implantation rate
Number of sacs with a heartbeat per number of embryo transferred
Measured: 12 weeks of gestation
Cumulative ongoing implantation rate
Number of sacs with a heartbeat per number of embryo transferred within one year of randomization
Measured: 12 weeks of gestation
Preterm birth rate
number of babies born before 37 weeks of gestation per total birth
Measured: 37 weeks
Very preterm birth
number of babies born before 32 weeks of gestation per total birth
Measured: 32 weeks
Low birth weight rate
number of babies with < 2500 gm per total birth
Measured: 40 weeks of gestation
Fertilization rate
fertilized oocytes with two pronuclei per Metaphase II injected
Measured: 6 days of culture
Cleavage rate
Cleaved embryo per fertilized oocyte
Measured: 6 days of culture
Rate of high-quality day-3 embryos
Embryos with seven or eight blastomeres of appropriate-size, and < 10% fragmentation by volume per fertilized oocyte
Measured: 6 days of culture
Blastocyst formation rate
Formed blastocyst on day 5/6 from fertilized oocytes
Measured: 6 days of culture
Rate of high-quality blastocyst
Blastocysts ≥ 3.1.1 grade per fertilized oocyte
Measured: 6 days of culture
Rate of utilizable blastocyst
Transferred and cryopreserved blastocysts from fertilized oocytes
Measured: 6 days of culture
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2019
- Study start1 Feb 2019
- Primary completion27 Mar 2020
- Study completion27 Mar 2020
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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,837 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ibn Sina Hospital
- Sponsor type
- Other government
- Collaborators
- Banoon IVF Center, Quena IVF Center, Amshag IVF Center
- Responsible party
- Principal investigator, Muhammad Fawzy, Ibn Sina Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03823235
- Sponsor's protocol ID
- IbnSina-Humidity
- Status last verified
- Jun 2020
- First submitted
- 27 Jan 2019
- Last updated
- 11 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Humidified Incubator Effect on Live Birth Rate After ICSI
- ClinicalTrials.gov ID
- NCT03823235
- Acronym / sponsor ID
- IbnSina-Humidity
- Conditions
- Infertility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,837 participants (actual)
- Lead sponsor
- Ibn Sina HospitalOther government
- Collaborators
- Banoon IVF Center, Quena IVF Center, Amshag IVF Center
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 27 Mar 2020 (actual)
- Study completion
- 27 Mar 2020 (actual)
- First posted
- 30 Jan 2019 (actual)
- 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.
Humidity for human embryo culture has been raised as essential with advantageous effect on clinical pregnancy and ongoing pregnancy after ICSI compared with a dry incubator. Whether the deleterious effect of dry culture would have an extended effect reaches the live birth rate needs to be examined. This RCT is to examine the effect of dry and humidified culture on live birth rates after ICSI.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Culture of human embryo in non-humidified incubator | Experimental | Other: Human embryo cultureEmbryo culture after in vitro fertilization in incubator with no humidity |
| Culture of human embryo in humidified incubator | No intervention | –Embryo culture after in vitro fertilization in incubator with humidity |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Women undergoing a first or second ICSI attempts
- Primary or secondary infertility with a BMI of < 31 kg/m2
- Duration of infertility of ≥ 18 months and normal baseline ultrasonography
- 18 to 40 years of age
- Tubal factor, male factor, polycystic ovary, unexplained infertility or combined factors
Key exclusion criteria (7 listed)
- Surgically-retrieved, frozen-thawed and pinpoint sperm or globozoospermia
- Thin endometrium
- Uterine anomaly and adhesion
- Adenomyosis
- Submucous myoma
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 |
|---|---|---|
| Human embryo culturehumidifed or dry incubator | Other | Culture of human embryo in non-humidified incubator |
Primary outcome
Live birth rate
Time frame: 30 weeks
Viable neonate after 30 weeks of gestation per initiated cycle
18 secondary outcomes
Cumulative live birth rate
Time frame: One year
Ongoing pregnancy rate
Time frame: 12 weeks of gestation
Cumulative ongoing pregnancy rate
Time frame: 12 weeks of gestation
Clinical pregnancy rate
Time frame: 7 weeks of gestation
Cumulative clinical pregnancy rate
Time frame: 7 weeks of gestation
Implantation rate
Time frame: 7 weeks of gestation
Cumulative implantation rate
Time frame: 7 weeks of gestation
Ongoing implantation rate
Time frame: 12 weeks of gestation
Cumulative ongoing implantation rate
Time frame: 12 weeks of gestation
Preterm birth rate
Time frame: 37 weeks
Very preterm birth
Time frame: 32 weeks
Low birth weight rate
Time frame: 40 weeks of gestation
Fertilization rate
Time frame: 6 days of culture
Cleavage rate
Time frame: 6 days of culture
Rate of high-quality day-3 embryos
Time frame: 6 days of culture
Blastocyst formation rate
Time frame: 6 days of culture
Rate of high-quality blastocyst
Time frame: 6 days of culture
Rate of utilizable blastocyst
Time frame: 6 days of culture
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2020.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Human embryo culture in people with Infertility, run by Ibn Sina Hospital at 3 sites in Egypt.
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 6 inclusion and 7 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: finished, as of the sponsor's last update on 11 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Egypt. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Live birth rate (time frame: 30 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 11 Jun 2020.