Infertility
Conditions
Brief summary
Stimulation protocols for IVF underwent several cycles of upgrading aiming to achieve reasonable outcomes with low-cost cycles. Antagonist protocols have been introduced as effective and comparable to long agonist regarding the outcomes. However, these protocols are still costly. Alternative protocols using progestin suppressions appear options for consideration.
Interventions
DRUGLH Suppression
Stimulation protocols
Sponsors
Ibn Sina Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
1. Women age of ≥ 18 to ≤ 40; 2. BMI of ≤ 31; 3. All indication for freeze-all 4. PCOS; 5. Women who have ≥ 1 year of primary or secondary infertility; 6. Tubal factor (unilateral, bilateral obstruction or salpingectomy); 7. Fresh ejaculate sperm of any count provided they have ≥ 1% normal forms and a motile fraction; 8. Women undergoing their first ICSI cycle or following a previous successful attempt; 9. Women undergoing only frozen-thawed embryo transfer; 10. Women with \> 8 mm endometrial thickness at the day of progesterone supplementation in the transfer cycle; 11. Women with no detected uterine abnormality on transvaginal ultrasound (e.g. submucosal myomas, polyps or septa).
Exclusion criteria
1. Unilateral oophorectomy; 2. Uterine pathology or abnormality; 3. Abnormal karyotyping for them or their male partners; 4. History of repeated abortions or implantation failure; 5. Uncontrolled diabetes; 6. Liver or renal disease; 7. History of malignancy or borderline pathology; 8. Endometriosis; 9. Plan for PGD-A; 10. Severe male factor includes surgical sperm retrieval or cryopreserved sperm.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Live Birth after first Vitrified-warmed cycle | 42 weeks of gestation | Delivery of one or more viable infants \> 20th weeks of gestation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Top-quality embryo on day 3 | Within 6 days of culture | (7-8 cells with appropriate-sizes blastomeres and less than 10% fragmentation by volume |
| Fertilization | Within 6 days of culture | presence of 2 pronuclei 17±1 hr after oocyte injection |
| Biochemical pregnancy | 14 days after egg retrieval | positive human chorionic Gonadotrophin (βhCG) ≥ 10 IU/L |
| Clinical pregnancy | within 12 weeks of gestation | registered sacs with a heartbeat on ultrasound at 7th weeks of gestation |
| Ongoing pregnancy | within 24 weeks of pregnancy | continued viable pregnancy \> 20th weeks of gestation |
| Embryo cleavage | Within 6 days of culture | Cleaved embryos per fertilized oocyte |
| Miscarriage | Within 20 weeks of pregnancy | loss of pregnancy ≤ 20th weeks of gestation |
| Term live-birth for vitrified-warmed transfer | Within 42 weeks of gestation | Delivery of one or more viable infants ≥37 weeks of gestation |
| Preterm Birth | Within 42 weeks of gestation | delivery of one or more viable infants \< 37th weeks of gestation |
| Very preterm birth | Within 42 weeks of gestation | delivery of one or more viable infants \< 32nd weeks of gestation |
| Blastocyst formation on day 5 or 6 | Within 6 days of culture | formed blastocysts per fertilized oocyte |
| Congenital malformation | Within one month of delivery | delivery of congenitally malformed babies |
| Still birth | Within 42 weeks of gestation | delivery of nonviable babies \> 20 weeks of gestation |
| Cumulative live birth | One year from randomization | Registered viable neonates after two vitrified-warmed transfers within one year of randomization |
| Top-quality blastocyst on day 5 | Within 6 days of culture | Rounded and dense inner cell mass with many trophectodermal cells creating a connected zone and a blastocoel more than 100% by volume; ≥ 311 grade per fertilized oocyte |
| Cryopreservation | Within 6 days of culture | Cryopreserved embryos per fertilized oocyte |
| Live-birth-implantation rate | Within 42 weeks of gestation | Number of viable neonates per number of embryos transferred |
| Utilized embryos | Within 6 days of culture | Number of cryopreserved plus transferred embryos per fertilized oocyte |
| Top-quality utilized embryos | Within 6 days of culture | Number of high-quality embryos transferred plus cryopreserved per fertilized oocyte |
| Metaphase II oocyte | Within 24 hours of oocyte retrieval | Mature oocyte per oocyte collected |
| Low birth weight babies | Within 24 hours of delivery | Babies with \< 2500 gm |
Countries
Egypt
Outcome results
None listed