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Hormonal Stimulation in IUI Treatment: Is Clomifen Combined With Ethinyl Estradiol Better, Worse or Equal to Menopur
Plain-language guide to NCT01569945: not phased randomized trial of HMG (Human Menopausal Gonadotropin), 371 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT01569945
- Phase
- not phased
- Status
- completed
- Start
- 2004-09
- Completion (planned or actual)
- 2010-12
- Participants
- 371 (actual)
- Design
- randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Subfertility
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
This registered not phased trial tested HMG (Human Menopausal Gonadotropin).
What is the best medication for hormonal stimulation in cycles with high intra-uterine insemination: tablets of Clomifen (5 days) followed by tablets of Ethinyl Estradiol (5 days) or daily injections with Human Menopausal Gonadotropin (Menopur)?
It had two arms (groups): Tablets (active comparator) and human menopausal gonadotropins (active comparator).
Clomifen (5 days) followed by Ethinyl Estradiol (5 days).
Daily Injections.
The registry classes the interventions as drug.
Who Took Part
Enrollment: 371 actual participants took part.
It was open to women only aged from 18 years up to 42 years.
Healthy volunteers could join, not only people with the condition.
The full record lists 4 inclusion and 3 exclusion criteria; among the exclusions: premature ovarian failure; medical history of tubal or ovarian surgery; tubal or pelvic adhesions.
How the Study Was Run
The set-up was randomized, parallel-group and open-label.
Random assignment meant chance, not the researchers, decided who got HMG (Human Menopausal Gonadotropin) and who got the comparison, which limits bias.
The HMG (Human Menopausal Gonadotropin) group and the comparison group ran side by side rather than switching.
Nothing was hidden in this open-label HMG (Human Menopausal Gonadotropin) study: the participants and staff both knew the treatment.
It started in 2004-09 with completion listed for 2010-12.
It ran at 1 site in Belgium.
Its stated primary purpose is treatment.
What Was Measured
Primary outcome: pregnancy rate (time frame: on average 30 days if not pregnant and 12 weeks if pregnant).
What This Means in Plain Language
Put simply, this is a not phased, randomized trial of HMG (Human Menopausal Gonadotropin) in 371 people.
The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the HMG (Human Menopausal Gonadotropin) compound page, all human trials.
Our Notes on the Compound
HMG (Human Menopausal Gonadotropin): Menotropins: a glycoprotein preparation that supplies follicle-stimulating hormone (FSH) and luteinizing hormone (LH) activity.
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.