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Trial · NCT05571111

Registered outcomes23

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

ListOutcomeTime frameDescription
PrimaryNumber of metaphase II (MII) oocytesOn the day of oocyte retrieval (2 days after triggering)
SecondaryNumber of oocytes retrievedOn the day of oocyte retrieval (2 days after triggering)
SecondaryNumber of fertilised (2 pronuclei) oocytesOn day 1 insemination (3 days after triggering)
SecondaryNumber and quality of embryos on day 3 after oocyte retrievalDay 3 after insemination (5 days after triggering)
SecondaryNumber and quality of blastocysts on day 5 after oocyte retrievalDay 5 after insemination (7 days after triggering)
SecondarySerum hormone concentrations of progesteroneBlood samples for analysis of circulating concentrations of progesterone will be drawn at several visits from day of triggering up to 22 days after triggering
SecondarySerum hormone concentrations of 17-OH-progesteroneBlood samples for analysis of circulating concentrations of 17-OH-progesterone will be drawn at several visits from day of triggering up to 22 days after triggering
SecondarySerum hormone concentrations of estradiolBlood samples for analysis of circulating concentrations of estradiol will be drawn at several visits from day of triggering up to 22 days after triggering
SecondarySerum hormone concentrations of follicle stimulating hormone (FSH)Blood samples for analysis of circulating concentrations of follicle stimulating hormone (FSH) will be drawn at several visits from day of triggering up to 22 days after triggering
SecondarySerum hormone concentrations of luteinising hormone (LH)Blood samples for analysis of circulating concentrations of luteinising hormone (LH) will be drawn at several visits from day of triggering up to 22 days after triggering
SecondaryPositive βhCG (positive serum βhCG test 13-15 days after transfer)20-22 days after triggering
SecondaryClinical pregnancy (at least one gestational sac 5-6 weeks after transfer)6-7 weeks after triggering
SecondaryVital pregnancy (at least one intrauterine gestational sac with fetal heart beat 5-6 weeks after transfer)6-7 weeks after triggering
SecondaryOngoing pregnancy (at least one intrauterine viable fetus 10-11 weeks after transfer)11-12 weeks after triggering
SecondarySerum hCG concentrations at end-of-stimulation, the day after triggering, at oocyte retrieval, on day 5 after oocyte retrieval (transfer), and on day 7-9 after oocyte retrieval (mid luteal phase)Blood samples for analysis of circulating concentrations of hCG will be drawn at several visits from day of triggering up to 9-11 days after triggering
SecondaryOvarian hyperstimulation syndrome (OHSS), overall and by timing, grade, and severity≤9 days after triggering of final follicular maturation (early OHSS), >9 days after triggering of final follicular maturation (late OHSS)Early OHSS is defined as OHSS with onset ≤9 days after triggering of final follicular maturation. Late OHSS is defined as OHSS with onset \>9 days after triggering of final follicular maturation.
SecondaryInjection site reactions (redness, pain, itching, swelling, and bruising) assessed by the subject following administration of investigational medicinal product (IMP)Immediately, 30 minutes, and 24 hours after injection
SecondaryTreatment-induced anti-hCG antibodies, overall as well as with neutralising capacityDay of triggering up until 19-28 days after triggering
SecondaryMulti-fetal gestationFrom day after blastocyst transfer (7 days after triggering) up until ongoing pregnancy (11-12 weeks after triggering)
SecondaryBiochemical pregnancyFrom day after blastocyst transfer (7 days after triggering) up until ongoing pregnancy (11-12 weeks after triggering)

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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