Infertility Clinical Trial
Official title:
Elective Blastocyst Vitrification for Endometrial Receptivity Enhancement in High-responder Patients Undergoing in Vitro Fertilisation/Intracytoplasmatic Sperm Injection (IVF/ICSI)
A randomised controlled open-label clinical trial to compare the clinical pregnancy rates between fresh embryo transfer and elective all-embryo vitrification with thawing and transfer in a subsequent cycle in high-responders
Two-arm randomised, single-centre, controlled open-label trial. Summarily, women undergoing
exogenous gonadotropin ovarian stimulation for ART in a gonadotropin-releasing hormone (GnRH)
antagonist down-regulated cycle and at high risk for ovarian hyperstimulation syndrome (OHSS)
will be included in either the control ("fresh embryo transfer") or intervention ("subsequent
vitrified-warmed embryo transfer") groups. Women in the control group will undergo GnRH
agonist triggering followed by intensified luteal phase support while the intervention group
will electively vitrify all viable embryos after GnRH triggering and perform the embryo
transfer (ET) in a subsequent unstimulated cycle.
Ovarian stimulation, ultrasound and hormonal monitoring, ovulation induction, oocyte
retrieval, embryology procedure, IVF and luteal support will be according to how they are
normally performed in our centre.
All women included will undergo artificial ovarian stimulation with GnRH antagonist
down-regulation with daily injections of either ganirelix (Orgalutran®) or cetrorelix
(Cetrotide®). Treating physicians will opt on which exogenous gonadotropins should be used
according to the patient's profile and preference and can include either recombinant follicle
stimulating hormone (FSH) or highly purified urinary human menopausal gonadotropin (HP-HMG).
Ovarian stimulation will commence after it is confirmed that the patient is not pregnant and
has basal levels of oestradiol, progesterone, FSH and luteinising hormone (LH). The
stimulation will be monitored simultaneously by pelvic ultrasound and hormonal analyses
(oestradiol, progesterone), starting on day 7 of stimulation and then every 1 to 3 days,
according to the individual endocrine profile and follicular development.
Final oocyte maturation will be triggered with 0.2 mg triptorelin (Decapeptyl®, Gonapeptyl®)
as soon as 3 follicles of ≥17 mm are observed. A GnRH agonist will be the preferred
triggering agent for both groups to reduce the risk of severe OHSS associated with human
chorionic gonadotropin (hCG) triggering in high-responders. Oocyte retrieval will be
performed 36 hours after hCG administration under either local anaesthesia with analgesic
premedication or general anaesthesia, according to patient preference.
IVF/ICSI will be performed, using the specimen of sperm made available by the male progenitor
on the day of oocyte retrieval.
The choice to transfer one or two embryos will be decided by the clinician at consultation
mainly depending on the patient's age and the number of embryos replaced in the previous
treatment cycles, according to Belgian law.
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