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Role of Suppression of Endometriosis With Progestins Before IVF-ET
Plain-language guide to NCT04500743: not phased randomized trial of Leuprolide, endometriosis, 134 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT04500743
- Phase
- not phased
- Status
- completed
- Start
- 2018-08-01
- Completion (planned or actual)
- 2019-10-31
- Participants
- 134 (actual)
- Design
- randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- IVF; Endometriosis; Pregnancy Rate; Progestins; GnRH-analogue
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
This registered not phased trial tested Leuprolide for endometriosis.
This study aimed to assess the role of Dienogest pretreatment for endometriosis suppression as compared to Gonadotropin-releasing hormone agonist (GnRHa) in patients with endometriosis pursuing IVF treatment.
It had two arms (groups): Dienogest (active comparator) and GnRH analogue (active comparator).
The registry classes the interventions as drug.
Who Took Part
The registry lists 134 actual participants took part.
It was open to women only aged from 30 years up to 40 years.
Healthy volunteers could join, not only people with the condition.
Examples of who could join: Confirmed diagnosis of endometriosis. Body mass index \< 35 Kg/m2.
The full record lists 2 inclusion and 3 exclusion criteria; among the exclusions: if they have been already on long-term down-regulation of the pituitary gland with gnrha for control of endometriosis; liver or kidney disease.
How the Study Was Run
The set-up was randomized, parallel-group and open-label.
The endometriosis participants were allocated by chance, so the Leuprolide group and the comparison group should start out alike.
Groups ran in parallel: each of the endometriosis participants stayed in one arm throughout.
Being open-label, the Leuprolide study did not mask who received what.
It started in 2018-08-01 with completion listed for 2019-10-31.
It ran at 1 site in Egypt.
Its stated primary purpose is treatment.
What Was Measured
Primary outcome: the number of retrieved oocytes (time frame: After the ovarian induction (3 months after the pre treatment with either GnRHa or Dienogest)).
It also tracked 7 secondary outcomes, for example the fertilization rate, the number of transferrable embryos, the cost of the treatment, pregnancy rate per cycle started, the clinical pregnancy rate per cycle started and the miscarriage rate.
What This Means in Plain Language
Put simply, this is a not phased, randomized trial of Leuprolide in 134 people with endometriosis.
The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Leuprolide compound page, Endometriosis research.
Our Notes on the Compound
Leuprolide: A 9-amino-acid GnRH analog (Lupron, Eligard) that lowers sex-hormone levels with ongoing use; used in prostate cancer, endometriosis and early puberty.
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.