ELONVA FLARE PROTOCOL: a new approach for poor responders in superovulation for In Vitro Fertilisation (IVF).

Authors
Category Primary study
Registry of TrialsANZCTR
Year 2019
INTERVENTION: All participants will receive a single subcutaneous injection of 150 mcg corifollitropin alfa (Elonva). The gonadotropin‐releasing hormone (GnRH) agonist flare protocol will use a day two of menses start of self‐administration of GnRH agonist medication; nafarelin (Synarel), 2 mg/mL, intranasal twice daily, followed by a day three administration of Elonva. Participants in the GnRH antagonist arm will self‐administer a subcutaneous injection of Elonva on day two of menses and Orgalutran 250mcg, once daily from day 5 of Elonva. All participants will receive daily recombinant follicle stimulating hormone (FSH) medication (Puregon), subcutaneously, 250 IU from day 7 of Elonva. All participants will receive a single “triggerâ€? injection of recombinant human chorionic gonadotropin (hCG) Ovidrel 250mcg, subcutaneosly when trigger criteria are met. In the unlikely eventuality of an excessive ovarian response is observed, those in the antagonist arm will receive leuprolide acetate (Lucrin) trigger, 2mg/0.4mls subcutaneously or the cycle will be cancelled. Those in the agonist flare arm will receive a half dose of Ovidrel, 125 mcg subcutaneously or the cycle will be cancelled. All participants will use vaginal progesterone, 200 mg twice daily for luteal support until pregnancy test. Duration of each drug may vary based on each participants' individual response to the fertility medications. Length of stimulation is approximately between 8‐12 days. Each participants will receive close monitoring throughout the stimulation phase with blood tests and transvaginal pelvic ultrasounds. The fertility clinic nurses and research nurse will be in regular contact with each participant throughout the trial to monitor adherence. CONDITION: Infertility; ; Infertility Reproductive Health and Childbirth ‐ Fertility including in vitro fertilisation PRIMARY OUTCOME: Effect of corrifollitropin alfa compered with daily recombinant FSH on circulating concentration of estradiol[Concentration at final blood test before hCG trigger] Effect of corrifollitropin alfa compered with daily recombinant FSH on circulating concentration of FSH[Concentration at final blood test before hCG trigger] Pharmacokinetics profile (AUC and T1/2) for Elonva Flare Protocol cycles assessed by serum analysis, [Daily from initiation of corifollitropin alfa for 5 days then alternate days for up to 12 days post‐enrolment.] SECONDARY OUTCOME: Number of oocytes obtained after use of corrifollitropin compared with daily recombinant FSH[Day of oocyte collection] Proportion of live births each arm of the study ; [This secondary timepoint will be up to 9 months following the last recorded pregnancy. ] INCLUSION CRITERIA: ‐ Female patients who are defined as a poor responder, according to the Poseidon criteria. (Poseidon Group 2 ‐Subgroup 2a only, Poseidon Group 3 & Poseidon Group 4) ‐ Female aged between 21‐ 42 years ‐ BMI 18.0‐35.0 ‐ Requiring IVF or Intracytoplasmic Sperm Injection (ICSI) and planned fertilisation of oocytes and fresh embryo transfer
Epistemonikos ID: c1d5d6b9e71c1188a56395f2e5b7e3ac0999aee3
First added on: Aug 24, 2024