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NCT Number: NCT03823235

Humidified Culture and Live Birth 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.

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Key information

Conditions

Infertility Genital Diseases Urogenital Diseases

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Qena Fertility Center, Qina, Qena Governorate, Egypt

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Surgically-retrieved, frozen-thawed and pinpoint sperm or globozoospermia
  • Thin endometrium
  • Uterine anomaly and adhesion
  • Adenomyosis
  • Submucous myoma
  • Endometriosis
  • Severe medical condition

Treatment and study plan

Human embryo culture

Other

humidifed or dry incubator

Primary outcomes

  1. Live birth rate

    Time frame: 30 weeks

    Viable neonate after 30 weeks of gestation per initiated cycle

Secondary outcomes

  1. Cumulative live birth rate

    Time frame: One year

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

  2. Ongoing pregnancy rate

    Time frame: 12 weeks of gestation

    Continued pregnancy after 12 weeks of gestation per initiated cycle

  3. Cumulative ongoing pregnancy rate

    Time frame: 12 weeks of gestation

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

  4. Clinical pregnancy rate

    Time frame: 7 weeks of gestation

    Ultrasound detect heartbeat after 7 weeks of gestation per initiated cycle

  5. Cumulative clinical pregnancy rate

    Time frame: 7 weeks of gestation

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

  6. Implantation rate

    Time frame: 7 weeks of gestation

    Number of sacs with a heartbeat per number of embryo transferred

  7. Cumulative implantation rate

    Time frame: 7 weeks of gestation

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

  8. Ongoing implantation rate

    Time frame: 12 weeks of gestation

    Number of sacs with a heartbeat per number of embryo transferred

  9. Cumulative ongoing implantation rate

    Time frame: 12 weeks of gestation

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

  10. Preterm birth rate

    Time frame: 37 weeks

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

  11. Very preterm birth

    Time frame: 32 weeks

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

  12. Low birth weight rate

    Time frame: 40 weeks of gestation

    number of babies with < 2500 gm per total birth

  13. Fertilization rate

    Time frame: 6 days of culture

    fertilized oocytes with two pronuclei per Metaphase II injected

  14. Cleavage rate

    Time frame: 6 days of culture

    Cleaved embryo per fertilized oocyte

  15. Rate of high-quality day-3 embryos

    Time frame: 6 days of culture

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

  16. Blastocyst formation rate

    Time frame: 6 days of culture

    Formed blastocyst on day 5/6 from fertilized oocytes

  17. Rate of high-quality blastocyst

    Time frame: 6 days of culture

    Blastocysts ≥ 3.1.1 grade per fertilized oocyte

  18. Rate of utilizable blastocyst

    Time frame: 6 days of culture

    Transferred and cryopreserved blastocysts from fertilized oocytes

Sponsors and collaborators

Lead sponsor

Ibn Sina Hospital

Other Gov

Collaborators

  • Amshag IVF Center
  • Banoon IVF Center
  • Quena IVF Center

Registry information

Official study title

Humidified Incubator Effect on Live Birth Rate After ICSI

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jan 30, 2019
Registry last updated
Jun 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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