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Age Versus Ovarian Reserve Markers Based Therapy in IVF (IVF)/Intracytoplasmic Sperm Injection (ICSI) Cycles
Plain-language guide to NCT01816789: phase 4 randomized trial of Buserelin, 194 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT01816789
- Phase
- phase 4
- Status
- terminated early
- Start
- 2013-03
- Completion (planned or actual)
- 2016-07
- Participants
- 194 (actual)
- Design
- randomized, double-blind, treatment
- Conditions studied
- In Vitro Fertilization; Ovarian Stimulation
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
The trial (phase 4) is built around Buserelin.
This randomized controlled trial has been designed for carrying out a comparison of new AMH (Anti-Müllerian Hormone)-based individualized treatment (using a nomogram) with the wide accepted age-based strategy.
It had two arms (groups): Group A: "age" (active comparator) and Group B: "nomogram" (experimental).
The registry classes the interventions as drug.
More on the Plan
External validation of the model is therefore crucial to assess the generalizability to other populations.
In the present RCT the new AMH-based individualized treatment will be compared to the wide accepted age-based strategy.
Primary endpoint: The percentage of women with an appropriate number (n=8-14) of retrieved oocytes in IVF/ICSI cycle.
Serum E2 levels on r-hCG day 2.
Who Took Part
194 actual participants took part.
It was open to women only aged from 18 years up to 40 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
The full record lists 1 inclusion and 1 exclusion criteria.
How the Study Was Run
Design: randomized, parallel-group and double-blind.
Because people in this Buserelin study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.
The Buserelin group and the comparison group ran side by side rather than switching.
Neither the participants nor the staff measuring them knew who was on Buserelin, so expectations could not easily colour the readings.
Those kept unaware of assignments: participant and investigator.
It started in 2013-03 with completion listed for 2016-07.
It ran at 1 site in Italy.
Its stated primary purpose is treatment.
What Was Measured
Researchers chose this as the main measure: The percentage of women with an appropriate number (N=8-14) of retrieved oocytes in IVF/ICSI cycles (time frame: 24 months).
What This Means in Plain Language
Put simply, this is a phase 4, randomized trial of Buserelin in 194 people.
It ended early (terminated); no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Buserelin compound page, all human trials.
Our Notes on the Compound
Buserelin: A GnRH analog (Suprefact) given by nasal spray or injection, used in prostate cancer and fertility treatment.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.