Luteal Support in Artificial Vitrified/Warmed Cycles With Low Progesterone (NCT04806919) | Clinical Trial Compass
CompletedPhase 3
Luteal Support in Artificial Vitrified/Warmed Cycles With Low Progesterone
Belgium87 participantsStarted 2021-04-02
Plain-language 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.
Who can participate
Age range18 Years – 43 Years
SexFEMALE
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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…