Luteal Support in Artificial Vitrified/Warmed Cycles With Low Progesterone
NCT ID: NCT04806919
Last Updated: 2024-02-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
242 participants
INTERVENTIONAL
2021-04-02
2025-01-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Control group: Amelgen ® 400 mg BID
Continue daily dose progesteron
No interventions assigned to this group
Intervention group: Amelgen ® 400 mg TID
Increase daily progesteron dose
Progesteron TID
increasing the dose
Interventions
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Progesteron TID
increasing the dose
Eligibility Criteria
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Inclusion Criteria
* Age ≥ 18 and \< 43 years old
* Body Mass Index (BMI) ≥ 18.5 kg/m2 and \< 35 kg/m2
* Less than 4 previous Assisted Reproductive Technologies (ART) cycles
* Current pregnancy wish
* Patients undergoing a single vitrified/warmed single transfer in an artificial prepared endometrium cycle (IVF or ICSI)
Exclusion Criteria
* Previous participation in this study
* Known reasons for impaired implantation (specifically: presence of a 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
* Active smoking
* Ongoing pregnancy
* Use of carbamazepine, rifampicin or phenytoin
* Those unable to comprehend the investigational nature of the proposed study
18 Years
43 Years
FEMALE
No
Sponsors
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University Hospital, Ghent
OTHER
Responsible Party
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Locations
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UZ Ghent
Ghent, , Belgium
AZ Delta
Roeselare, , Belgium
Countries
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Facility Contacts
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Other Identifiers
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2020-004112-10
Identifier Type: -
Identifier Source: org_study_id
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