Study population and design
failure or recurrent miscarriage, insulin-dependent diabetes, venous thromboembolism
ENDOMETRIOSIS, SYSTEMIC DISEASE, UNEXPLAINED INFERTILITY, Y-CHROMOSOME MICRODELETIONS, HYDROSALPINX, THYROID DYSFUNCTION, CAVITY, THROMBOPHLEBITIS, EVENTS, SYSTEMIC DISEASES, INSULIN-DEPENDENT DIABETES
This was a single-centre, randomized, controlled, open-label, pilot study. Women who were planning to undergo FET-HRT in our centre were screened and consequently invited to participate in this study. All FET-HRT cycles were performed in a tertiary referral centre (Brussels IVF, Centre for Reproductive Medicine, Universitair Ziekenhuis Brussel, Belgium) between October 2018 and January 2021, and the follow up period was 12 weeks from FET. We included all women between the age of 18 and 40 years with unexplained infertility and showing a normal uterine cavity, undergoing either IVF or ICSI with a GnRH agonist or antagonist protocol (Table Inclusion/Exclusion criteria ▪ Women aged ≥ 18 and < 40 years▪ Frozen embryo transfer with artificial preparation▪ Normal uterine cavity▪ IVF/ICSI▪ IVF cycle with GnRH agonist or antagonist▪ Single day 5 blastocyst transfer▪ Top quality embryo (at least Bl 3BA) at the moment of ET▪ Participants can be included only once in the trial▪ Body mass index of ≤ 18 and ≥ 29▪ Previous diagnosis of PCOS/POI▪ Endometriosis stage 3 and 4▪ Previous diagnosis of hydrosalpinx▪ Systemic diseases such as thyroid dysfunction, unless corrected▪ History of recurrent implantation failure or recurrent miscarriage▪ PGT-A and PGT-M cycles▪ Oocytes donation cycles▪ Known abnormal karyotype of the subject or of her partner/sperm donor, as applicable, depending on the source of sperm used for insemination in this trial. In case partner sperm will be used and the sperm production is severely impaired (concentration < 1 million/mL) normal karyotype, including no Y-chromosome microdeletion, must be documented▪ Any known clinically significant systemic disease (e.g. insulin-dependent diabetes)▪ Active arterial or venous thromboembolism or severe thrombophlebitis, or a history of these events▪ Current or past (within 90 days prior to screening) smoking habit of more than 10 cigarettes per day
Furthermore, only the first single Day 5 blastocyst transfer with an excellent quality embryo (at least Bl 3BA) was included. Women with a BMI lower than 18 or higher than 29 kg/m