Ovarian Stimulation Single Injection Elonva

NCT02414737 | Completed Phase 3

• 1 other identifier: AU/1/2 C8B110
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Infertility

Outcome Measures

Primary Outcomes (1)

• Oocyte maturity - number of mature oocytes (metaphase II oocytes) retrieved in IVF cycle

  number of mature oocytes (metaphase II oocytes) retrieved in IVF cycle

  IVF cycle (2 weeks approximately)

Other Outcomes (1)

• cryopreservation of embryos - number of good quality embryos available for cryopreservation

  IVF cycle

Study Arms (1)

corifollitrophin alfa

EXPERIMENTAL

corifollitrophin alfa used as COH stimulant in IVF

Drug: corifollitrophin alfa

Interventions

corifollitrophin alfa DRUG

use of a single dose of corifollitrophin alfa to provide adequate controlled ovarian hyperstimulation during IVF treatment

Also known as: Elonva

corifollitrophin alfa

Eligibility Criteria

• Age: 18 Years - 37 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• Flinders Fertility: lead
• Flinders University: collaborator

Study Sites (1)

Flinders Fertility

Bedford Park, South Australia, 5042, Australia

Location

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Officials

• Kelton Tremellen, MD PhD

  Flinders University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Reproductive Medicine

Study Record Dates

• First Submitted: April 8, 2015
• First Posted: April 13, 2015
• Study Start: February 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: June 21, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)