Ovarian Stimulation Single Injection Elonva

• Status: Completed
• Trial end date: 2017-06-01
• Target enrollment: 0
• Participant gender: Female

Summary

We would like to propose that it may be possible to use a solitary dose of Elonva (corifollitrophin alpha) as the sole gonadotrophin (FSH) stimulant for the vast majority of women undergoing IVF, assuming that it is possible that "coasting" (withholding short acting rFSH) from day 8 of the stimulation until trigger/ oocyte retrieval will still result in a significant number of mature oocytes being produced and an acceptable pregnancy rate.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Flinders Fertility
• Collaborator: Flinders University

Criteria

Inclusion Criteria:

• Undergoing a GnRH antagonist cycle of IVF as part of their personal fertility treatment

• Eligible for the use of the 150 mcg dose of Elonva according to Australian PBS requirements (weight > 60 kg, antral follicle count < 20)

• Intention of undergoing a fresh embryo transfer.

• No major sperm quality issues (ejaculate sperm concentration > 5 million/ ml, motility > 25% neat sample). ICSI for the indication of poor morphology would be acceptable for trial enrollment.

• Maternal age 18-37 years inclusive.

Exclusion Criteria:

• Low ovarian reserve (antral follicle count 2-10 mm < 7, early follicular phase FSH > 10 IU/L, < 4 oocytes prior IVF cycle on a dose of rFSH > 150 IU).

• Ovarian pathology (PCOS, ovarian cyst, endometrioma, poor trans-vaginal ultrasound ovary access).

• 2 or more previous cycles of IVF (stimulated cycles) in which a live birth pregnancy did not result, or one prior stimulated cycle of IVF and 2 or more frozen embryo transfer cycles without a live birth outcome (possible implantation failure).

• Significant pelvic pathology likely to impair embryo implantation (fibroids, polyps, uterine septum, hydrosalpinx).

• Intention to freeze all embryos with nil fresh transfer (pre-implantation genetic screening, oncology fertility preservation).

• Known renal impairment

• Use of a long down regulation or "flare" IVF protocol.