Embryo Loss, IVF, Luteal Phase Defect
Conditions
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 (defined as \< 10 mcg/l) on the day of blastocyst transfer.
Interventions
DRUGProgesteron TID
increasing the dose
Sponsors
University Hospital, Ghent
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 43 Years
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ongoing pregnancy rate | 7 gestational weeks (+ or - 1 week) | visualization of an embryo with a heart beat |
Secondary
| Measure | Time frame |
|---|---|
| Endometrial impaction: Corelation between the change in endometrial thickness on day of embryo transfer and ongoing pregnancy rate | 7 gestational weeks (+ or - 1 week) |
Countries
Belgium
Outcome results
None listed