ClinicalTrials.gg
CompletedNCT03823235Updated Jun 11, 2020

Humidified Culture and Live Birth After ICSI

An interventional study of Human embryo culture in Infertility, sponsored by Ibn Sina Hospital. Completed at 3 sites in Egypt. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2020-06-11.

Sponsored by Ibn Sina Hospital · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
1,837
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
Female
01

Study 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. This RCT is to examine the effect of dry and humidified culture on live birth rates after ICSI.

02

Conditions studied

  • Infertility

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03

In context

Infertility

2,085 studies on the registry are indexed under Infertility; 357 are open to participants now.

This study's enrollment of 1,837 is above the median of 135 across 1,412 interventional studies indexed under Infertility.

Browse Infertility studies →

Lead sponsor

Ibn Sina Hospital is the lead sponsor of 28 studies on the registry; none are open to participants now.

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

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Women undergoing a first or second ICSI attempts
  • Primary or secondary infertility with a 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

Exclusion criteria

Exclusion Criteria:

  • Surgically-retrieved, frozen-thawed and pinpoint sperm or globozoospermia
  • Thin endometrium
  • Uterine anomaly and adhesion
  • Adenomyosis
  • Submucous myoma
  • Endometriosis
  • Severe medical condition
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
1,837 participants (actual)

Study arms

  • Experimental
    Culture of human embryo in non-humidified incubator

    Embryo culture after in vitro fertilization in incubator with no humidity

    Other: Human embryo culture

  • No intervention
    Culture of human embryo in humidified incubator

    Embryo culture after in vitro fertilization in incubator with humidity

Interventions

  • OtherHuman embryo culture

    humidifed or dry incubator

06

What researchers measure

Primary outcomes

  1. Live birth rate

    Viable neonate after 30 weeks of gestation per initiated cycle

    Time frame: 30 weeks

Secondary outcomes

  1. Cumulative live birth rate

    Viable neonate after 30 weeks of gestation after one fresh and/or one frozen-warmed transfer per initiated cycle

    Time frame: One year

  2. Ongoing pregnancy rate

    Continued pregnancy after 12 weeks of gestation per initiated cycle

    Time frame: 12 weeks of gestation

  3. Cumulative ongoing pregnancy rate

    Continued pregnancy after 12 weeks of gestation per initiated cycle within one year of randomization

    Time frame: 12 weeks of gestation

  4. Clinical pregnancy rate

    Ultrasound detect heartbeat after 7 weeks of gestation per initiated cycle

    Time frame: 7 weeks of gestation

  5. Cumulative clinical pregnancy rate

    Ultrasound detect heartbeat after 7 weeks of gestation per initiated cycle within one year of randomization

    Time frame: 7 weeks of gestation

  6. Implantation rate

    Number of sacs with a heartbeat per number of embryo transferred

    Time frame: 7 weeks of gestation

  7. Cumulative implantation rate

    Number of sacs with a heartbeat per number of embryo transferred within one year of randomization

    Time frame: 7 weeks of gestation

  8. Ongoing implantation rate

    Number of sacs with a heartbeat per number of embryo transferred

    Time frame: 12 weeks of gestation

  9. Cumulative ongoing implantation rate

    Number of sacs with a heartbeat per number of embryo transferred within one year of randomization

    Time frame: 12 weeks of gestation

  10. Preterm birth rate

    number of babies born before 37 weeks of gestation per total birth

    Time frame: 37 weeks

  11. Very preterm birth

    number of babies born before 32 weeks of gestation per total birth

    Time frame: 32 weeks

  12. Low birth weight rate

    number of babies with \< 2500 gm per total birth

    Time frame: 40 weeks of gestation

  13. Fertilization rate

    fertilized oocytes with two pronuclei per Metaphase II injected

    Time frame: 6 days of culture

  14. Cleavage rate

    Cleaved embryo per fertilized oocyte

    Time frame: 6 days of culture

  15. Rate of high-quality day-3 embryos

    Embryos with seven or eight blastomeres of appropriate-size, and \< 10% fragmentation by volume per fertilized oocyte

    Time frame: 6 days of culture

  16. Blastocyst formation rate

    Formed blastocyst on day 5/6 from fertilized oocytes

    Time frame: 6 days of culture

  17. Rate of high-quality blastocyst

    Blastocysts ≥ 3.1.1 grade per fertilized oocyte

    Time frame: 6 days of culture

  18. Rate of utilizable blastocyst

    Transferred and cryopreserved blastocysts from fertilized oocytes

    Time frame: 6 days of culture

07

Study locations

3 sites
  • Banon Assiut
    Assiut, Egypt
  • Qena Fertility Center
    Qena, 123456, Egypt
  • IbnSina IVF Center
    Sohag, Egypt
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Feb 2019 to primary completion in Mar 2020, 13 months.

Of 385 non-industry interventional studies with no phase under Infertility, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 46. This study's 13 months is below that.

Counting every sponsor, half of 416 studies reached it within 24 months; a quarter within 10 and three quarters within 43.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 27, 2019
First posted
Jan 30, 2019
StartActual
Feb 1, 2019
Primary completionActual
Mar 27, 2020
CompletionActual
Mar 27, 2020
Last update
Jun 11, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 11, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03823235
Lead sponsor
Ibn Sina Hospital
Collaborators
Banoon IVF Center, Quena IVF Center, Amshag IVF Center
Responsible party
Muhammad Fawzy (Lab Director, Ibn Sina Hospital) — Principal investigator
First posted
Jan 30, 2019
Start date
Feb 1, 2019
Primary completion
Mar 27, 2020
Completion
Mar 27, 2020
Last update
Jun 11, 2020

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.

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