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IVF Versus Gonadotropin Therapy in Women With CC Resistant PCOS
Plain-language guide to NCT02458963: phase 4 randomized trial of HMG (Human Menopausal Gonadotropin), pcos. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT02458963
- Phase
- phase 4
- Status
- withdrawn
- Start
- 2016-01
- Completion (planned or actual)
- 2017-04
- Participants
- n/a (actual)
- Design
- randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Infertility; Polycystic Ovarian Syndrome
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
This registered phase 4 trial tested HMG (Human Menopausal Gonadotropin) for pcos.
It had two arms (groups): IVF group (active comparator) and Gonadotropin group (active comparator).
Women will undergo one full IVF cycle.
The registry classes the interventions as drug and procedure.
More on the Plan
Women will be randomly divided into two groups; IVF group and gonadotropin group.
Women in the IVF group will undergo one full IVF cycle.
Who Took Part
It was open to women only aged from 20 years up to 35 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Infertile women with PCOS as defined by the Rotterdam criteria.
The full record lists 2 inclusion and 6 exclusion criteria; among the exclusions: age \< 20 or \> 35 years; presence of any infertility factor other than anovulatory pcos; previous history of ovarian surgery or surgical removal of one ovary.
How the Study Was Run
Design: randomized, parallel-group and open-label.
Because people in this HMG (Human Menopausal 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 pcos participants stayed in one arm throughout.
Everyone knew when HMG (Human Menopausal Gonadotropin) was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.
It started in 2016-01 with completion listed for 2017-04.
It ran at 2 sites in Egypt (2).
Its stated primary purpose is treatment.
What Was Measured
Researchers chose this as the main measure: Live birth rate (time frame: 9 months).
It also tracked 4 secondary outcomes, for example Clinical pregnancy rate, Multifetal pregnancy rate, Miscarriage rate and Incidence of early ovarian hyperstimulation syndrome (OHSS).
What This Means in Plain Language
Put simply, this is a phase 4, randomized trial of HMG (Human Menopausal Gonadotropin) in people with pcos.
It was withdrawn before enrolling anyone; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the HMG (Human Menopausal Gonadotropin) compound page, PCOS research.
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.