Trial · NCT01857310
Registered outcomes38
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
21 to 38 of 38
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Secondary | Major Neonatal Complications | Delivery | Abstracted from hospital records and medical charts: includes bronchopulmonary dysplasia, necrotizing enterocolitis, severe intraventricular hemorrhage, periventricular leukomalacia, and retinopathy of prematurity |
| Secondary | Structural Malformations | Delivery | Abstracted from birth record: includes major (n = 21; 6 with known genetic cause), minor (n = 6), and unclassified (n = 2) defects Structural birth defects: includes hydronephrosis/ureteropelvic junction obstruction, transposition of the great arteries, renal agenesis, cleft lip, club feet, multicystic/dysplastic kidney, tetralogy of fallot, gastroschisis, atrioventricular septal defects, other oral-facial defects, other cardiovascular defects, other CNS defects, other eye defects, other oral-facial defects, other anomalies, other syndromes |
| Secondary | Severe Maternal Morbidity | Delivery | Abstracted from delivery record: including postpartum hemorrhage, anemia requiring transfusion, sepsis, seizure, HELLP syndrome or preeclampsia with pulmonary edema |
| Secondary | Fertilization Rate Per Cycle, % | Up to 9 months of fertility treatment post-randomization | Among participants in the IVF stratum Oocytes will be assessed 16-18 hours after insemination or microinjection to determine whether fertilization occurred. Fertilization will be considered normal if two pronuclei and two polar bodies are identified. Oocytes without visible pronuclei will be considered unfertilized. Oocytes with more than two pronuclei will be considered abnormally fertilized, and will thus be discarded. |
| Secondary | Number of Good Quality Embryos on Day 5 Per Cycle | Up to 9 months of fertility treatment post-randomization | Among participants in the IVF stratum For couples who meet criteria for blastocyst culture, embryos will be graded 5 days after fertilization based on Society for Assisted Reproductive Technologies (SART) morphology criteria. |
| Secondary | Percentage of Good Quality Embryos on Day 5 Per Cycle | Up to 9 months of fertility treatment post-randomization | Among participants in the IVF stratum For couples who meet criteria for blastocyst culture, embryos will be graded 5 days after fertilization based on Society for Assisted Reproductive Technologies (SART) morphology criteria. |
| Secondary | Number of Embryos Transferred Per Cycle | Up to 9 months of fertility treatment post-randomization | Among participants in the IVF stratum |
| Secondary | Number of Embryos Cryopreserved Per Cycle | Up to 9 months of fertility treatment post-randomization | Among participants in the IVF stratum |
| Secondary | Sperm Penetration Per Cycle, % | Up to 9 months of fertility treatment post-randomization | Among participants in the IVF stratum |
| Secondary | Cells on Day 3 Per Embryo Per Cycle | Up to 9 months of fertility treatment post-randomization | Among participants in the IVF stratum |
| Secondary | Cells on Day 3 Per Embryo Per Cycle, Categorical | Up to 9 months of fertility treatment post-randomization | Number of cells per embryo among women in the IVF stratum |
| Secondary | Cells on Day 5 Per Embryo Per Cycle, Categorical | Up to 9 months of fertility treatment post-randomization | Among participants in the IVF stratum |
| Secondary | Embryo Morphology on Day 3 Per Cycle, Categorical | Up to 9 months of fertility treatment post-randomization | Among participants in the IVF stratum Embryos will be scored three days after fertilization according to the size and shape of blastomeres and to their degree of fragmentation. Veeck LL. Oocyte assessment and biological performance. Ann N Y Acad Sci 1988;541:259-74.:259-74. |
| Secondary | Embryo Morphology on Day 5 Per Cycle, Categorical | Up to 9 months of fertility treatment post-randomization | Among participants in the IVF stratum For couples who meet criteria for blastocyst culture, embryos will be graded 5 days after fertilization based on Society for Assisted Reproductive Technologies (SART) morphology criteria. |
| Secondary | Method of Fertilization Per Cycle | Up to 9 months of fertility treatment post-randomization | Among participants in the in vitro fertilization (IVF) stratum: method of fertilization classified into intracytoplasmic sperm injection (ICSI) and other |
| Secondary | Quality of Embryos Transferred Per Cycle, Categorical | Up to 9 months of fertility treatment post-randomization | Among participants in the IVF stratum Embryonic grading based on Society for Assisted Reproductive Technologies (SART) morphology criteria |
| Secondary | Chromosomal Complement of Embryo Per Cycle | Up to 9 months of fertility treatment post-randomization | Among participants in the IVF stratum Chromosomal complement in the embryo assessed using methodology cited by Rubio et al. Rubio C, Rodrigo L, Mir P et al. Use of array comparative genomic hybridization (array-CGH) for embryo assessment: clinical results. Fertil Steril 2013 March 15;99(4):1044-8. |
| Other | Reproductive Hormones and Other Measured Biomarkers | 4 or 6 months | Urinary, serum, and salivary concentrations of reproductive hormones, particularly androgens, proteomic analysis of human sperm and cardiometabolic risk factors and markers of oxidative stress, as well as measures of trace elements in toenails (collected at month 4 clinic visit). Biospecimens have been collected but laboratory analysis still needs to be done to be able to evaluate these endpoints. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT01857310/registered?page=2