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Trial · NCT05263388

Registered outcomes11

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryNumber of Oocytes RetrievedOn day of oocyte retrieval (Up to 22 days after start of stimulation)The number of oocytes retrieved was recorded at the oocyte retrieval visit.
SecondaryNumber of Follicles (Total) at End-of-stimulationAt end-of-stimulation (up to 20 stimulation days)Counted by transvaginal ultrasound for the right and left ovary for each subject.
SecondarySize of the Follicles at End-of-stimulationAt end-of-stimulation (up to 20 stimulation days)Counted by ultrasound for the right and left ovary for each subject.
SecondarySerum Concentrations of Estradiol at End-of-stimulationAt end-of-stimulation (up to 20 stimulation days)Blood samples for analysis of circulating concentrations of estradiol were drawn.
SecondarySerum Concentrations of Progesterone at End-of-stimulationAt end-of-stimulation (up to 20 stimulation days)Blood samples for analysis of circulating concentrations of progesterone were drawn.
SecondaryNumber of Fertilized OocytesOn day 1 after oocyte retrieval (up to 23 days after start of stimulation)The number of pronuclei were counted after insemination. Fertilized oocytes with 2 pronuclei (2PN) were regarded as correctly fertilized.
SecondaryFertilization RateOn day 1 after oocyte retrieval (up to 23 days after start of stimulation)The fertilization rate was defined as the number of oocytes with 2PN divided by the number of oocytes retrieved.
SecondaryNumber of Blastocysts and Number of Good Quality BlastocystsOn Day 5 or Day 6 (as applicable) after oocyte retrieval (up to 27 or 28 days after start of stimulation)
Number of blastocysts and number of good quality blastocysts on Day 5 or 6 were presented. The quality evaluation of blastocysts consisted of assessment of three parameters, as per the Gardner \& Schoolcraft system: blastocyst expansion and hatching status (graded: 1-6), inner cell mass (graded: A-D) and trophectoderm (graded: A-D). A good-quality blastocyst was defined as a blastocyst of grade 3BB or higher.
SecondaryTotal Gonadotropin DoseUp to 20 stimulation daysCalculated by start dates, end dates and daily dose of investigational medicinal product (IMP).
SecondaryNumber of Stimulation DaysUp to 20 stimulation daysCalculated by start dates and end dates.
SecondaryProportion of Subjects With Early Ovarian Hyperstimulation Syndrome (OHSS) (Overall and by Grade) and/or Preventive Interventions for Early OHSSUp to 9 days after triggering of final follicular maturation
Early OHSS is defined as OHSS with onset ≤9 days after triggering of final follicular maturation. Classification of grade was according to Golan's classification system, and all OHSS cases were graded as mild, moderate or severe.

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.

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