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Repeated Injection of GnRH Agonist to Reduce Ovarian Hyperstimulation Syndrome
Plain-language guide to NCT02022241: not phased non-randomized trial of Triptorelin, 80 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT02022241
- Phase
- not phased
- Status
- status unknown
- Start
- 2012-07
- Completion (planned or actual)
- 2015-12
- Participants
- 80 (estimated)
- Design
- non-randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Infertility and at High Risk of OHSS
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
This registered not phased trial tested Triptorelin.
However, lower oocyte yield was reported in patients with lower luteinizing hormone (LH) level post trigger with single injection of GnRH agonist, which might be related to the shorter duration and lower amount of LH induced by GnRH agonist.
It had 1 arm (groups): Repeated GnRHa (experimental).
Patients were triggered with repeated GnRHa.
The registry classes the interventions as drug.
More on the Plan
This was a prospective cohort study of all women attending the Center for Reproductive Medicine, Department of Gynecology and Obstetrics, Nanfang Hospital, affiliated with Southern Medical University for in vitro fertilization and/or intracytoplasmic sperm injection .
Women at high risk of OHSS who received IVF and/or intracytoplasmic sperm injection (ICSI) treatment with a flexible GnRH antagonist protocol were recruited to participate in this study.
Who Took Part
The registry lists 80 planned participants were the target.
It was open to women only aged up to 40 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Patients with polycystic ovarian syndrome. Patients with polycystic ovarian morphology on ultrasound. Patients who previously experienced an ovarian stimulation cycle, with a high response to gonadotrophins.
The full record lists 3 inclusion and 2 exclusion criteria; among the exclusions: patients undergoing coasting; patients with past ovarian surgery.
How the Study Was Run
It was run as a non-randomized, single-group and open-label study.
Everyone knew when Triptorelin was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.
Everyone received the same intervention, so there was no separate comparison group inside the trial.
It started in 2012-07 with completion listed for 2015-12.
It ran at 1 site in China.
Its stated primary purpose is treatment.
What Was Measured
The main thing measured (primary outcome): clinical pregnancy rate per transfer cycle (time frame: 1month post embryo transfer). numbers of patients having OHSS (time frame: 2 weeks post trigger with repeated GnRHa). oocyte yield (time frame: oocyte retrieval day (34 to 38 hours post the first trigger with GnRHa)).
It also tracked 4 secondary outcomes, for example serum luteinizing hormone level 12 hours post first trigger, serum luteinizing hormone level 24 hours post first trigger, fertilization rate and implantation rate.
What This Means in Plain Language
Put simply, this is a not phased, non-randomized trial of Triptorelin in 80 people.
Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Triptorelin compound page, all human trials.
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.