Infertility
Conditions
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.
Interventions
OTHERHuman embryo culture
humidifed or dry incubator
Sponsors
Banoon IVF Center
Quena IVF Center
Amshag IVF Center
Ibn Sina Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Live birth rate | 30 weeks | Viable neonate after 30 weeks of gestation per initiated cycle |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ongoing pregnancy rate | 12 weeks of gestation | Continued pregnancy after 12 weeks of gestation per initiated cycle |
| Cumulative ongoing pregnancy rate | 12 weeks of gestation | Continued pregnancy after 12 weeks of gestation per initiated cycle within one year of randomization |
| Clinical pregnancy rate | 7 weeks of gestation | Ultrasound detect heartbeat after 7 weeks of gestation per initiated cycle |
| Cumulative clinical pregnancy rate | 7 weeks of gestation | Ultrasound detect heartbeat after 7 weeks of gestation per initiated cycle within one year of randomization |
| Implantation rate | 7 weeks of gestation | Number of sacs with a heartbeat per number of embryo transferred |
| Cumulative implantation rate | 7 weeks of gestation | Number of sacs with a heartbeat per number of embryo transferred within one year of randomization |
| Ongoing implantation rate | 12 weeks of gestation | Number of sacs with a heartbeat per number of embryo transferred |
| Cumulative ongoing implantation rate | 12 weeks of gestation | Number of sacs with a heartbeat per number of embryo transferred within one year of randomization |
| 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 |
| Very preterm birth | 32 weeks | number of babies born before 32 weeks of gestation per total birth |
| Low birth weight rate | 40 weeks of gestation | number of babies with \< 2500 gm per total birth |
| Fertilization rate | 6 days of culture | fertilized oocytes with two pronuclei per Metaphase II injected |
| Cleavage rate | 6 days of culture | Cleaved embryo per fertilized oocyte |
| 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 |
| Blastocyst formation rate | 6 days of culture | Formed blastocyst on day 5/6 from fertilized oocytes |
| Rate of high-quality blastocyst | 6 days of culture | Blastocysts ≥ 3.1.1 grade per fertilized oocyte |
| Rate of utilizable blastocyst | 6 days of culture | Transferred and cryopreserved blastocysts from fertilized oocytes |
| Preterm birth rate | 37 weeks | number of babies born before 37 weeks of gestation per total birth |
Countries
Egypt
Outcome results
None listed