Trial · NCT05499052
Registered outcomes22
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 22
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Use of the algorithm-based individualized dosing regimen (daily dose of REKOVELLE® administered) | Up to day 1 of REKOVELLE® stimulation | Calculated with body weight and AMH serum level to define the daily dose of REKOVELLE® |
| Primary | Daily dose of REKOVELLE® | From day 1 up to day 20 of REKOVELLE® stimulation | |
| Primary | Number of days of treatment with REKOVELLE® | From day 1 up to day 20 of REKOVELLE® stimulation | |
| Primary | REKOVELLE® Dose changes | From day 1 up to day 20 of REKOVELLE® stimulation | Dose changes is the discretion of the investigator |
| Primary | Use of the Algorithm dosing Application | Up to day 1 of REKOVELLE® stimulation | Use of the Ferring developed dosing app for the daily dose calculation by answering yes/no |
| Primary | Use of GnRH protocol for Lutenizing Hormone surge suppression | Up to day 10 | Defined as a choice between GnRH agonist and GnRH antagonist |
| Primary | Type of drug used for triggering of follicle maturation | Between Day 8 and Day 14 | Defined as a choice between hCG or GnRH |
| Primary | Luteal phase support | 24-72 hours after oocyte-retrieval | Type and the length of luteal phase support is the discretion of the investigator. Decided as a choice between Progesterone, Oestrogen and hCG |
| Secondary | Rate of ongoing pregnancy (≥1 intrauterine viable fetus 10-11 weeks after embryo transfer) in the fresh cycle | 10-11 weeks after embryo transfer | |
| Secondary | Rate of ongoing pregnancy (≥1 intrauterine viable fetus 10-11 weeks after embryo transfer) following the fresh cycle, including also the first frozen embryo transfer | 10-11 weeks after embryo transfer | |
| Secondary | Number of oocytes retrieved | Following 1st cycle with REKOVELLE® (each cycle range is 5-20 days, average 9 days) at 34-36 hours | |
| Secondary | Number of oocytes/embryos/blastocysts frozen | Following 1st cycle with REKOVELLE® (each cycle range is 5-20 days, average 9 days) after oocyte retrieval | |
| Secondary | Number of embryos/blastocysts transferred | Following 1st cycle with REKOVELLE® (each cycle range is 5-20 days, average 9 days) after oocyte retrieval | |
| Secondary | Quality of fresh embryos or blastocysts transferred (excellent, good, fair, other) | Following 1st cycle with REKOVELLE® (each cycle range is 5-20 days, average 9 days) after oocyte retrieval | |
| Secondary | Positive signs of pregnancy (clinical pregnancy) | Following 1st cycle with REKOVELLE® (each cycle range is 5-20 days, average 9 days) Up to 5-6 weeks after embryo transfer | Clinical pregnancy defined as least one gestational sac. |
| Secondary | Positive signs of pregnancy (Positive Human chorionic gonadotropin (hCG) test or urine pregnancy test) | Following 1st cycle with REKOVELLE® (each cycle range is 5-20 days, average 9 days) Up to 10-11 weeks after embryo transfer | |
| Secondary | Pregnancy loss in women with embryo/blastocyst transfer (biochemical pregnancy, spontaneous/elective abortion, ectopic pregnancy, vanishing twin) | Up to 10-11 weeks after embryo transfer | Biochemical pregnancy is defined as positive beta hCG (βhCG) test but no gestational sac is observed on later transvaginal ultrasound, or menstruation is reported. Spontaneous 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. Elective abortion is defined as induced abortion done at the request of the woman for other than therapeutic reasons. Ectopic pregnancy is defined as extrauterine gestational sac with or without fetal heart beat as documented by ultrasound or surgery. Vanishing 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. |
| Secondary | Cycle cancellation before or after oocyte pick-up and reason for cycle cancellation | At consultation visit where cycle cancellation decided up to 10-11 weeks after embryo transfer | Date when the investigator decides to cancel cycle 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, OHSS, subject choice, other) |
| Secondary | Adverse drug reactions (ADRs) | During 1st cycle with REKOVELLE® (each cycle range is 5-20 days, average 9 days), Up to 10-11 weeks after embryo transfer. | Adverse drug reactions (ADRs) defined by the investigator |
| Secondary | Ovarian hyperstimulation syndrome (OHSS) (including mild/moderate/severe) | During 1st cycle with REKOVELLE® (each cycle range is 5-20 days, average 9 days), Up to 10-11 weeks after embryo transfer. | OHSS defined by the investigator (including mild/moderate/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.
For software
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT05499052/registered