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Trial · NCT04163458

Outcomes54

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYNumber of Fertilized (2 Pronuclei [2PN]) OocytesOn Day 1 after oocyte retrieval (up to 23 days after start of stimulation)Fertilized oocytesMEAN
SECONDARYPositive Beta Human Chorionic Gonadotropin (βhCG) Rate10-14 days after blastocyst transfer (up to approximately 6 weeks after start of stimulation)ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYClinical Pregnancy Rate5-6 weeks after blastocyst transfer (up to approximately 10 weeks after start of stimulation)ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYOngoing Pregnancy Rate8-9 weeks after blastocyst transfer (up to approximately 13 weeks after start of stimulation)ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYEarly Pregnancy Loss8-9 weeks after blastocyst transfer (up to approximately 13 weeks after start of stimulation)Only participants who had a positive βhCG test were eligible.ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYFollicular Development on Stimulation Day 6At stimulation Day 6FolliclesMEAN
SECONDARYFollicular Development on Last Day of StimulationAt last day of stimulation (up to 20 stimulation days)FolliclesMEAN
SECONDARYSerum Follicle-stimulating Hormone (FSH) ConcentrationAt Day 6, last day of stimulation (up to 20 stimulation days) and at oocyte retrieval (up to 22 days after start of stimulation)Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.IU/LMEDIAN
SECONDARYSerum Anti-Müllerian Hormone (AMH) ConcentrationAt the last day of stimulation (up to 20 stimulation days) and at end-of-trial (up to approximately 6 months from the start of screening)Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.pmol/LMEDIAN
SECONDARYHuman Chorionic Gonadotropin (hCG) ConcentrationAt Day 6 and last day of stimulation (up to 20 stimulation days)Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.IU/LMEDIAN
SECONDARYLuteinizing Hormone (LH) ConcentrationAt Day 6 and last day of stimulation (up to 20 stimulation days)Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.IU/LMEDIAN
SECONDARYProgesterone (P4) ConcentrationAt Day 6 and last day of stimulation (up to 20 stimulation days)Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.ng/mLMEDIAN
SECONDARYEstradiol (E2) ConcentrationAt stimulation Day 6 and last day of stimulation (up to 20 stimulation days)Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.pg/mLMEDIAN
SECONDARYNumber of Oocytes RetrievedOn day of oocyte retrieval (up to 22 days after start of stimulation)OocytesMEAN
SECONDARYNumber of Metaphase II (MII) OocytesOn day of oocyte retrieval (up to 22 days after start of stimulation)Only participants with Oocytes retrieved were eligible.MII OocytesMEAN
SECONDARYFertilization RateOn Day 1 after oocyte retrieval (up to 23 days after start of stimulation)Only participants with Oocytes retrieved were eligible.PercentageMEAN
SECONDARYNumber of Blastocysts and Number of Good-Quality Blastocysts 5 Days After Oocyte RetrievalOn Day 5 after oocyte retrieval (up to 27 days after start of stimulation)BlastocystsMEAN
SECONDARYTotal Gonadotropin DoseUp to 20 stimulation daysIUMEAN
SECONDARYNumber of Stimulation DaysUp to 20 stimulation daysDaysMEAN
SECONDARYProportion of Participants With Ovarian Hyperstimulation Syndrome (OHSS)
≤9 days after triggering of final follicular maturation (early OHSS), >9 days after triggering of final follicular maturation until 21-28 days after last IMP dose or up to ongoing pregnancy 8-9 weeks after transfer in pregnant participants (late OHSS)
Percentage of participantsNUMBER

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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