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Menopur And Rekovelle Combination Study
Plain-language guide to NCT03483545: not phased interventional trial of HMG (Human Menopausal Gonadotropin), 160 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT03483545
- Phase
- not phased
- Status
- completed
- Start
- 2018-07-17
- Completion (planned or actual)
- 2019-07-31
- Participants
- 160 (actual)
- Design
- na, open label (everyone knows who gets what), other
- Conditions studied
- Fertility Disorders
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
In this not phased trial, researchers set out to test HMG (Human Menopausal Gonadotropin).
It had 1 arm (groups): Follitropin delta and HP-hMG (experimental).
Follitropin delta combined with highly purified human menopausal gonadotrophin.
The registry classes the interventions as combination product.
Who Took Part
Enrollment: 160 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: Women 18 to 40 years of age undergoing their first IVF/ICSI cycle. Regular menstrual cycles of 24-35 days. Presence of both ovaries. Ejaculated sperm (fresh or frozen) for insemination.
The full record lists 6 inclusion and 8 exclusion criteria; among the exclusions: inability to consent; endometriosis stage iii and iv; history of recurrent miscarriages defined as ≥ 3 consecutive losses.
How the Study Was Run
It was run as a single-group and open-label study.
Nothing was hidden in this open-label HMG (Human Menopausal Gonadotropin) study: the participants and staff both knew the treatment.
Everyone received the same intervention, so there was no separate comparison group inside the trial.
It started in 2018-07-17 with completion listed for 2019-07-31.
It ran at 4 sites in Canada (4).
Its stated primary purpose is other.
What Was Measured
The main thing measured (primary outcome): Evaluate the number of utilizable blastocysts on Day 5 or Day 6 of embryo culture (time frame: 6 days of embryo culture).
It also tracked 2 secondary outcomes, for example Evaluate the safety profile of the REKOVELLE - Menopur mixed protocol algorithm.
What This Means in Plain Language
Put simply, this is a not phased trial of HMG (Human Menopausal Gonadotropin) in 160 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.