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Supplementation With Human Chorionic Gonadotropin (hCG) During Controlled Ovarian Stimulation With Recombinant Follicle-stimulating Hormone (FSH) for In Vitro Fertilisation
Plain-language guide to NCT00844311: phase 4 randomized trial of hCG (human chorionic gonadotropin), 60 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00844311
- Phase
- phase 4
- Status
- completed
- Start
- 2009-02
- Completion (planned or actual)
- 2010-06
- Participants
- 60 (estimated)
- 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
The trial (phase 4) is built around hCG (human chorionic gonadotropin).
It had four arms (groups): Control arm (active comparator), one (experimental), one (experimental) and one (experimental).
The registry classes the interventions as drug.
Who Took Part
Enrollment: 60 planned participants were the target.
It was open to women only aged from 25 years up to 37 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Females with indication for COS and IVF;. Age between 25-37 years;. BMI \>18 and \< 30 kg/m2;. A regular menstrual cycle between 24 and 35 days and presumed to be ovulatory;. Tubal or unexplained infertility, including endometriosis stage I/II;.
The full record lists 12 inclusion and 17 exclusion criteria; among the exclusions: history of or current pcos, endometriosis stage iii/iv or severe male factor requiring icsi;; history of severe ovarian hyperstimulation syndrome (ohss);; presence of unilateral or bilateral hydrosalpinx at ultrasound;.
How the Study Was Run
The set-up was randomized, parallel-group and open-label.
The participants were allocated by chance, so the hCG (human chorionic gonadotropin) group and the comparison group should start out alike.
The hCG (human chorionic gonadotropin) group and the comparison group ran side by side rather than switching.
Being open-label, the hCG (human chorionic gonadotropin) study did not mask who received what.
It started in 2009-02 with completion listed for 2010-06.
It ran at 1 site in Denmark.
Its stated primary purpose is treatment.
What Was Measured
The main thing measured (primary outcome): Total number of top-quality embryos at day 3.
What This Means in Plain Language
Put simply, this is a phase 4, randomized trial of hCG (human chorionic gonadotropin) in 60 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.