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
- 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]
- Registration Number
- EUCTR2020-004112-10-BE
- Lead Sponsor
- Ghent University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Female
- Target Recruitment
- 807
The study population is aimed at a broad population undergoing IVF or ICSI treatment undergoing a single vitrified/warmed single transfer in an artificial prepared endometrium cycle. Subjects who meet all of the following will be considered eligible to participate in the clinical trial:
•Informed consent form (ICF) dated and signed
•Age = 18 and < 43 years old at the time of signing ICF
•Body Mass Index (BMI) = 18.5 kg/m² and < 35 kg/m²
•Less than 5 failed previous Assisted Reproductive Technologies (ART) cycles since live birth or in case of no live birth: since start fertility treatment
•Current pregnancy wish
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 807
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Subjects who meet any of the following criteria will be excluded from participation in this study:
•Simultaneous participation in another clinical study
•Previous participation in this study
•Known reasons for impaired implantation
(specifically: presence of an hydrosalpinx; presence of a type I, II or III fibroid; Asherman's syndrome; uterine malformations, intrauterine adhesions, = grade 3 endometriosis according to the ASRM classification, endometrial tuberculosis)
•Repeated miscarriages
(> 2 miscarriages)
•Untreated and uncontrolled thyroid dysfunction
•Tumors of the ovary, breast, uterus, pituitary or hypothalamus
•Abnormal vaginal bleeding without a known/diagnosed cause
•Ovarian cysts or enlarged ovaries
•Fibroid tumors of the uterus incompatible with pregnancy
•Malformations of the reproductive organs incompatible with pregnancy
•Previous antibiotic hypersensitivity reactions (streptomycin and/or neomycin)
•Risk factors for thromboembolic events, such as a personal or family history, severe obesity or thrombophilia
•Ongoing pregnancy
•Use of carbamazepine, rifampicin or phenytoin
•Those unable to comprehend the investigational nature of the proposed study
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method