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Trial Comparing hCG Triggering Versus GnRH Agonist Triggering in PCOS Patients
Plain-language guide to NCT01683513: phase 4 randomized trial of hCG (human chorionic gonadotropin), pcos, 120 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT01683513
- Phase
- phase 4
- Status
- completed
- Start
- 2011-11
- Completion (planned or actual)
- 2015-02
- Participants
- 120 (actual)
- Design
- randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Infertility; PCOS
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
In this phase 4 trial, researchers set out to test hCG (human chorionic gonadotropin) for pcos.
In this study the investigators compare the traditional way of triggering with a new way in patients with Poly Cystic Ovary Syndrome (PCOS).
The investigators also compare the number of mature oocytes, embryo's and pregnancy rate.
It had two arms (groups): humaan chorion gonadotropine (no intervention) and GnRH agonist + 1500E hCG (active comparator).
Ovulation induction with 5000E hCG.
Ovulation induction with GnRH agonist and 1500E hCG one hour after egg retrieval.
The registry classes the interventions as drug.
Who Took Part
Enrollment: 120 actual participants took part.
It was open to women only aged from 18 years up to 38 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: ICSI patients below 38 years. 1, 2 and 3e IVF cycle. Body Mass Index (BMI) less than 32.
The full record lists 4 inclusion and 1 exclusion criteria; among the exclusions: endocrinal diseases or problems.
How the Study Was Run
Design: randomized, parallel-group and open-label.
Random assignment meant chance, not the researchers, decided who got hCG (human chorionic gonadotropin) and who got the comparison, which limits bias.
Groups ran in parallel: each of the pcos participants stayed in one arm throughout.
Being open-label, the hCG (human chorionic gonadotropin) study did not mask who received what.
It started in 2011-11 with completion listed for 2015-02.
It ran at 1 site in Belgium.
Its stated primary purpose is treatment.
What Was Measured
Primary outcome: MII oocytes (time frame: patients will be followed during the stimulation with an average of 10 days). 2 Pro Nuclei (2PN) fertilization (time frame: 24h after ICSI).
It also tracked 2 secondary outcomes, for example implantation rate and OHSS.
What This Means in Plain Language
Put simply, this is a phase 4, randomized trial of hCG (human chorionic gonadotropin) in 120 people with pcos.
The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the hCG (human chorionic gonadotropin) compound page, PCOS research.
Our Notes on the Compound
hCG (human chorionic gonadotropin): An LH analog that drives Leydig-cell testosterone production.
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.