Implantation Enhancement by Elective Cryopreservation of All Viable Embryos
Condition: Infertility; OHSS
MeSH terms: Infertility
Study type: Interventional

Summary: 
      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
    

Detailed description: 
      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.
    

Intervention name(s): Vitrification with subsequent-cycle embryo thawing/transfer; Intensified luteal phase support for fresh embryo transfer; Pregnyl®; Utrogestan®; Progynova®; CryoBioSystem®
Intervention type(s): Procedure; Procedure; Drug; Drug; Drug; Device
Intervention description(s): The vitrification process will be performed under the same conditions of all other vitrification procedures usually performed in our centre. In summary, vitrification will be accomplished using closed high security straws (CryoBioSystem®) in combination with dimethylsulfoxide, ethylene glycol and sucrose as cryoprotectants (Irvine ScientificR Freeze Kit®).
In the meantime, patients will wait for a subsequent cycle before starting exogenous hormone therapy for endometrial preparation.; A single administration of 1500 IU of exogenous hCG (Pregnyl®) 1 hour after oocyte retrieval followed by daily vaginally-administered progesterone 200 mg tid (Utrogestan®) and oestradiol valerate 2 mg bid (Progynova®).; 1500 IU; 200 mg tid; 2 mg bid; CryoBioSystem® in combination with dimethylsulfoxide, ethylene glycol and sucrose as cryoprotectants (Irvine ScientificR Freeze Kit®) closed in high security straws
Other intervention name(s): hCG; Vaginal progesterone; Estradiol valerate
Intervention MeSH terms: Chorionic Gonadotropin; Estradiol; Progesterone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment