WHO ICTRP trial
Study of the effect of an additional administration of Amelgen® 400 mg in women…
EUCTR2020-004112-10-BE · EU Clinical Trials Register · Authorised
Key facts
| Trial ID | EUCTR2020-004112-10-BE |
|---|---|
| Public title | Study of the effect of an additional administration of Amelgen® 400 mg in women with a low progesterone value on the day of embryo replacement |
| Scientific title | Randomized controlled trial comparing micronized progesterone (Amelgen ®) 400 mg BID versus 400 mg TID for luteal support in artificial vitrified/warmed single blastocyst transfer cycles with low progesterone on day of embryo transfer - PROTECTA |
| Primary sponsor | Ghent University Hospital |
| Registry | EU Clinical Trials Register |
| Recruitment status | Authorised |
| Study type | Interventional clinical trial of medicinal product |
| Phase | Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no |
| Countries | Belgium |
| Conditions | Patients who undergo artificial vitrified/warmed single blastocyst transfer cycles with low progesterone (defined as <10mcg/l) on day of embryo transfer. ;Therapeutic area: Body processes [G] - Reproductive physiologi cal processes [G08] |
| Interventions | Trade Name: Amelgen Pharmaceutical Form: Vaginal tablet INN or Proposed INN: PROGESTERONE CAS Number: 57-83-0 Current Sponsor code: PROGESTERONE Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 400- Trade… |
| Registration date | Nov 13, 2020 |
| Target size | 807 |
| Secondary IDs | PROTECTA |
| Registry page | clinicaltrialsregister.eu |
At a glance
- No Results available
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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: