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Effect of Treatment With Corifollitropin Alpha in Vitro Fertilization in Patients With Poor Ovarian Response.
Plain-language guide to NCT02118051: phase 3 randomized trial of hCG (human chorionic gonadotropin), 234 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT02118051
- Phase
- phase 3
- Status
- completed
- Start
- 2013-09
- Completion (planned or actual)
- 2017-06
- Participants
- 234 (actual)
- Design
- randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Infertility
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
This registered phase 3 trial tested hCG (human chorionic gonadotropin).
It had two arms (groups): CFA , hMG,Ganirelix,choriogonadotropin alfa,progesterone. (experimental) and hMG ,Ganirelix,choriogonadotropin alfa,progesterone (active comparator).
The registry classes the interventions as drug.
More on the Plan
Different criteria for the definition of low response, different tests to assess ovarian reserve and different threshold values for each has been used.
The IVF treatment is known to affects the physical and mental condition in patients with infertility , being the excess emotional stress one of the most important reasons for discontinuation of treatment.
Who Took Part
The registry lists 234 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.
Examples of who could join: \- Age ≥ 18 years old. \- Signed informed consent to perform IVF and participation in this study. \- Due to characteristics of their center not perform treatments in patients. Have a history of surgical or medical treatment as a risk factor for POR. Patients witch had have a poor ovarian response in response to the ovarian controlled stimulation (previous cycle after conventional stimulation with ≤ 3 oocytes).
How the Study Was Run
It was run as a randomized, parallel-group and open-label study.
Because people in this hCG (human chorionic gonadotropin) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.
Groups ran in parallel: each of the participants stayed in one arm throughout.
Being open-label, the hCG (human chorionic gonadotropin) study did not mask who received what.
It started in 2013-09 with completion listed for 2017-06.
It ran at 1 site in Spain.
Its stated primary purpose is treatment.
What Was Measured
Primary outcome: Rate of evolutionary gestation in each cycle (time frame: 20 week of gestation). oocytes (MII) rate by patient (time frame: participants will be followed for the duration of the cycle,an expected average of 8-16 days).
It also tracked 1 secondary outcome, for example Number of Participants with Adverse Events.
What This Means in Plain Language
Put simply, this is a phase 3, randomized trial of hCG (human chorionic gonadotropin) in 234 people.
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, all human trials.
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.