Status:
RECRUITING
Luteal Support in Artificial Vitrified/Warmed Cycles With Low Progesterone
Lead Sponsor:
University Hospital, Ghent
Conditions:
IVF
Embryo Loss
Eligibility:
FEMALE
18-43 years
Phase:
PHASE3
Brief Summary
The study aims to evaluate the effect of an increased dose of vaginal progesterone supplementation on the incidence of ongoing pregnancy for patients with a suboptimal serum progesterone level (define...
Eligibility Criteria
Inclusion
- Informed consent form (ICF) dated and signed
- 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
- Simultaneous participation in another clinical study
- 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
Key Trial Info
Start Date :
April 2 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2025
Estimated Enrollment :
242 Patients enrolled
Trial Details
Trial ID
NCT04806919
Start Date
April 2 2021
End Date
January 1 2025
Last Update
February 5 2024
Active Locations (2)
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1
UZ Ghent
Ghent, Belgium, 9000
2
AZ Delta
Roeselare, Belgium