ELONVA FLARE PROTOCOL: a new approach for poor responders in superovulation for In Vitro Fertilisation (IVF).
ELONVA FLARE PROTOCOL: a new approach for poor responders in superovulation for IVF aiming to develop detailed pharmacokinetic (PK) and pharmacodynamic (PD) profiles for Elonva Flare cycles.
UNSW
20 participants
May 5, 2021
Interventional
Conditions
Summary
There is an unmet need for an effective way to treat poor responding patients to superovulation for IVF. We predict the Elonva Flare Protocol (EFP) may be an innovative way to treat fertility patients who are told their chances of conception are low. We hypothesise that the unique PK/PD profile of Corifollitropin alfa (CFA) will maximise follicle stimulating hormone (FSH) exposure and follicular recruitment in the critical early follicular phase. Additionally, we hypothesise that the unique PK/PD properties of Elonva when combined with a short agonist flare cycle will maximise FSH exposure at the critical time of antral follicle recruitment, leading to a higher oocyte yield and improved pregnancy rate. EFP involves sufficiently fewer injections when compared with antagonists or long down regulated cycles. We predict that this will be attractive to patients, with less injection associated stress.
Eligibility
Inclusion Criteria4
- 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
Exclusion Criteria6
- Egg freeze cycle
- Severe male factor defined as <1 million/mL
- Previous cancer treatment or any other exogenous factor affecting ovarian function
- PCO or PCOS according to Rotterdam criteria
- Patients with a significant pre-existing physical or mental health condition.
- Unable to fully give informed consent to participate
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
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 “trigger” 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.
Locations(1)
View Full Details on ANZCTR
For the most up-to-date information, visit the official listing.
ACTRN12619001593123