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Effect of Prolonged GnRh Agonists on Results of Intracytoplasmic Sperm Injection (ICSI ) in Endometrioma Patients
Plain-language guide to NCT02737800: not phased randomized trial of Triptorelin, endometriosis, 88 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT02737800
- Phase
- not phased
- Status
- completed
- Start
- 2016-04
- Completion (planned or actual)
- 2017-08
- Participants
- 88 (actual)
- Design
- randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Endometrioma
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
In this not phased trial, researchers set out to test Triptorelin for endometriosis.
Investigators compare ICSI results for endometrioma patients with or without cyst aspiration if more than 5cm \&with or without GnRh agonists for all endometrioma patients.
It had four arms (groups): 1A endometrioma more than 5cm (active comparator), 1B endometrioma more than 5cm control (sham comparator), 2A endometrioma less than 5cm (active comparator) and 2B endometrioma less than 5cm control (sham comparator).
Endometrioma aspiration Standard long stimulation protocol \& ICSI.
The registry classes the interventions as drug and procedure.
More on the Plan
Standard long protocol Group 2B;GnRh suppression for 3 months then standard long protocol.
Who Took Part
Enrollment: 88 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 3 exclusion criteria; among the exclusions: follicle stimulating hormone(fsh)10 or more; gnrh suppression in the last 12 months.
How the Study Was Run
The set-up was randomized, parallel-group and open-label.
Because people in this Triptorelin study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.
The Triptorelin group and the comparison group ran side by side rather than switching.
Being open-label, the Triptorelin study did not mask who received what.
It started in 2016-04 with completion listed for 2017-08.
It ran at 1 site in Egypt.
Its stated primary purpose is treatment.
What Was Measured
Researchers chose this as the main measure: Number of patients with urine pregnancy test positive 2 weeks after embryo transfer (time frame: 5 months).
What This Means in Plain Language
Put simply, this is a not phased, randomized trial of Triptorelin in 88 people with endometriosis.
The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Triptorelin compound page, Endometriosis research.
Our Notes on the Compound
Triptorelin: A 10-amino-acid GnRH analog (Trelstar, Decapeptyl, Triptodur) used in prostate cancer, early puberty and fertility protocols.
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.