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Trial · NCT04503707

Registered outcomes35

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

ListOutcomeTime frameDescription
PrimaryDaily dose of REKOVELLE administered (for naïve and non-naïve subjects)At the end of the stimulation protocol (up to 30 days)
PrimaryDuration of treatment with REKOVELLE (for naïve and non-naïve subjects)From first until last day of REKOVELLE treatment (up to 30 days)
PrimaryUse of the dosing App (for naïve and non-naïve subjects)At visit when the daily dose of REKOVELLE is decided (up to 2 hours)
PrimaryType of Gonadotropin-Releasing Hormone (GnRH) used (for naïve and non-naïve subjects)At visit (up to 2 hours) during the REKOVELLE treatment period
PrimaryDuration of treatment with GnRH (for naïve and non-naïve subjects)At the end of the ovarian controlled stimulation (up to 2 weeks)
PrimaryTreatment used for the triggering of follicle maturation (for naïve and non-naïve subjects)At the last visit during the REKOVELLE treatment period (from 5 to 30 days)
PrimaryTreatment used for Luteal phase support (for naïve and non-naïve subjects)From start of REKOVELLE treatment until 10-11 weeks after embryo transferDecided as a choice between Progesterone, Oestrogen and hCG
SecondaryRate of Ongoing Pregnancy (for naïve and non-naïve subjects)Up to 10-11 weeks after transferOngoing pregnancy is defined as at least one intrauterine viable fetus, 10-11 weeks after first fresh or frozen embryo/blastocyst transfer.
SecondaryNumber of oocytes retrieved (for naïve and non-naïve subjects)At visit (up to 2 hours) at 36 hours after completed REKOVELLE treatment
SecondaryNumber of oocytes/embryos/blastocysts frozen (for naïve and non-naïve subjects)At Day 3 after oocyte retrieval
SecondaryQuality of fresh or frozen embryos or blastocysts transferred (excellent, good, fair, other) (for naïve and non-naïve subjects)At Day 3, 5 or 6 after oocyte retrieval
SecondaryImplantation rate (for naïve and non-naïve subjects)Up to 10-11 weeks after transferImplantation rate is defined as number of intrauterine viable fetus after transfer divided by the number of embryos/blastocysts transferred.
SecondaryPositive human chorionic gonadotropin (hCG) test (for naïve and non-naïve subjects)Up to 10-11 weeks after transferProportion of subjects with positive hCG test.
SecondaryClinical pregnancy rate (for naïve and non-naïve subjects)Up to 5-6 weeks after transferClinical pregnancy is defined as least one gestational sac.
SecondaryIncidence of biochemical pregnancy (for naïve and non-naïve subjects)Up to 10-11 weeks after transferBiochemical pregnancy is defined as positive beta hCG (βhCG) test but no gestational sac is observed on later transvaginal ultrasound, or menstruation is reported.
SecondaryIncidence of spontaneous abortion (for naïve and non-naïve subjects)Up to 10-11 weeks after transferSpontaneous abortion is defined as positive βhCG test but all intrauterine gestational sacs without fetal heart beat as documented by ultrasound, or there are no viable fetuses observed by ultrasound.
SecondaryIncidence of elective abortion (for naïve and non-naïve subjects)Up to 10-11 weeks after transferElective abortion is defined as induced abortion done at the request of the woman for other than therapeutic reasons.
SecondaryIncidence of vanishing twins (for naïve and non-naïve subjects)Up to 10-11 weeks after transferVanishing twin is defined as spontaneous disappearance of an intrauterine gestational sac with or without heart beat in a pregnancy where one viable fetus remains as documented by ultrasound.
SecondaryIncidence of ectopic pregnancy (for naïve and non-naïve subjects)Up to 10-11 weeks after transferEctopic pregnancy is defined as extrauterine gestational sac with or without fetal heart beat as documented by ultrasound or surgery.
SecondaryProportion of subjects with cycle cancellation (for naïve and non-naïve subjects)Up to 10-11 weeks after transfer
Cancellation could be done before oocyte pick up (due to poor ovarian response, excessive ovarian response, any illness which prevents oocyte collection procedure, subject not taking hCG injection at the correct time, subject choice, other) or after oocyte pick up (due to no oocytes collected, no oocytes fertilized, abnormal fertilization, abnormal embryo development, no embryo development, ovarian hyperstimulation syndrome (OHSS), subject choice, other)

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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