None listed
Conditions
Brief 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.
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,
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.
Sponsors
UNSW
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
21 Years to 42 Years
Healthy volunteers
No
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
Exclusion criteria
- 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
Outcome results
None listed