Humidified Culture and Live Birth After ICSI

• Sponsor: Ibn Sina Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT03823235
• Collaborator: Banoon IVF Center (Other), Quena IVF Center (Other), Amshag IVF Center (Other)
• Enrollment: 1,837
• Locations: 3
• Arms: 2
• Actual Duration (Months): 13.8
• Patients Per Site: 612.3
• Patients Per Site Per Month: 44.4

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Infertility	Other: Human embryo culture	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 1837 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Other
• Official Title: Humidified Incubator Effect on Live Birth Rate After ICSI
• Actual Study Start Date: Feb 1, 2019
• Actual Primary Completion Date: Mar 27, 2020
• Actual Study Completion Date: Mar 27, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Culture of human embryo in non-humidified incubator Embryo culture after in vitro fertilization in incubator with no humidity	Other: Human embryo culture; humidifed or dry incubator
No Intervention: Culture of human embryo in humidified incubator Embryo culture after in vitro fertilization in incubator with humidity

Outcome Measures

Primary Outcome Measures

1. Live birth rate [30 weeks]

   Viable neonate after 30 weeks of gestation per initiated cycle

Secondary Outcome Measures

1. Cumulative live birth rate [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 [12 weeks of gestation]

   Continued pregnancy after 12 weeks of gestation per initiated cycle

3. Cumulative ongoing pregnancy rate [12 weeks of gestation]

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

4. Clinical pregnancy rate [7 weeks of gestation]

   Ultrasound detect heartbeat after 7 weeks of gestation per initiated cycle

5. Cumulative clinical pregnancy rate [7 weeks of gestation]

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

6. Implantation rate [7 weeks of gestation]

   Number of sacs with a heartbeat per number of embryo transferred

7. Cumulative implantation rate [7 weeks of gestation]

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

8. Ongoing implantation rate [12 weeks of gestation]

   Number of sacs with a heartbeat per number of embryo transferred

9. Cumulative ongoing implantation rate [12 weeks of gestation]

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

10. Preterm birth rate [37 weeks]

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

11. Very preterm birth [32 weeks]

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

12. Low birth weight rate [40 weeks of gestation]

    number of babies with < 2500 gm per total birth

13. Fertilization rate [6 days of culture]

    fertilized oocytes with two pronuclei per Metaphase II injected

14. Cleavage rate [6 days of culture]

    Cleaved embryo per fertilized oocyte

15. Rate of high-quality day-3 embryos [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 [6 days of culture]

    Formed blastocyst on day 5/6 from fertilized oocytes

17. Rate of high-quality blastocyst [6 days of culture]

    Blastocysts ≥ 3.1.1 grade per fertilized oocyte

18. Rate of utilizable blastocyst [6 days of culture]

    Transferred and cryopreserved blastocysts from fertilized oocytes

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 40 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Banon Assiut	Assiut		Egypt
2	Qena Fertility Center	Qena		Egypt	123456
3	IbnSina IVF Center	Sohag		Egypt

Sponsors and Collaborators

• Ibn Sina Hospital
• Banoon IVF Center
• Quena IVF Center
• Amshag IVF Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Muhammad Fawzy, Lab Director, Ibn Sina Hospital
• ClinicalTrials.gov Identifier: NCT03823235
• Other Study ID Numbers: IbnSina-Humidity
• First Posted: Jan 30, 2019
• Last Update Posted: Jun 11, 2020
• Last Verified: Jun 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Infertility

Study Results

No Results Posted as of Jun 11, 2020