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Trial · NCT01185704

Registered outcomes15

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

ListOutcomeTime frameDescription
PrimaryEstradiol (E2) Levels on r-hCG Dayr-hCG day (end of stimulation cycle [approximately 15 days])
SecondarySerum Luteinizing Hormone (LH) and Follicle Stimulating Hormone (FSH) LevelsDay 1
SecondarySerum Estradiol (E2) LevelsDay 1
SecondarySerum Progesterone (P4) LevelsDay 1
SecondaryAnti Mullerian Hormone (AMH) LevelsDay 0
SecondaryNumber of Follicles Greater Than or Equal (>=) to 17 mm (For Day 1 Protocol) or 19 mm (For Day 7 Protocol) on r-hCG Dayr-hCG day (end of stimulation cycle [approximately 15 days])
SecondaryNumber and Quality of Oocytes RetrievedOocytes retrieval day (36 +/- 2 hours post r-hCG day [end of stimulation cycle {approximately 15 days}])
Oocyte retrieval is a technique used in in-vitro fertilization (IVF) in order to remove oocytes from the ovary of the female participant, enabling fertilization outside the body. Oocytes were classified into 4 different categories based on their quality: mature, fractured, immature and inseminated oocytes.
SecondaryTotal Dose of Recombinant Human Follicle Stimulating Hormone (r-hFSH)Day 1 up to r-hCG day (end of stimulation cycle [approximately 15 days])
SecondaryPercentage of Fertilized Oocytes RetrievedOocytes retrieval day (36 +/- 2 hours post r-hCG day [end of stimulation cycle {approximately 15 days}])Oocytes were fertilized using Intra-cytoplasmic Sperm Injection (ICSI) technique which is an IVF procedure in which a single sperm is injected directly into an egg under a microscope.
SecondaryNumber of EmbryosDay 2-3 post oocytes retrieval day (36 +/- 2 hours post r-hCG day [end of stimulation cycle {approximately 15 days}])Embryo is defined as the product of the zygote, two or three days after fertilization of the oocytes.
SecondaryNumber of BlastocystsDay 5-6 post oocytes retrieval day (36 +/- 2 hours post r-hCG day [end of stimulation cycle {approximately 15 days}])Blastocyst is an embryo, five or six days after fertilization, with an inner cell mass, outer layer of trophectoderm and a fluid-filled blastocoele cavity.
SecondaryNumber of Transferred EmbryosDay 2-3 post Oocytes retrieval day (36 +/- 2 hours post r-hCG day [end of stimulation cycle {approximately 15 days}])Embryo transfer is the procedure in which one or more embryos are placed in the uterus.
SecondaryImplantation Rate5 weeks post oocytes retrieval day (36 +/- 2 hours post r-hCG day [end of stimulation cycle {approximately 15 days}])Implantation rate per reporting group was measured as the number of gestational sacs observed, divided by the number of embryos transferred multiplied by 100.
SecondaryPercentage of Participants With Clinical Pregnancy10 weeks post r-hCG day (end of stimulation cycle [approximately 15 days])Clinical pregnancy was defined as pregnancy diagnosed by ultrasonographic visualization of one or more gestational sacs or definitive clinical signs of pregnancy. It excludes ectopic pregnancy.
SecondaryNumber of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)Day 1 up to end of study (15 days post last administration of study drug)
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered. A Serious Adverse Event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. To avoid the participant/event combination double-count AEs and SAEs are reported separately.

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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