Prospective Randomized Trial Comparing Corifollitropin-alfa Late Start vs. Corifollitropin-alfa Standard Start in Expected Poor, Normal and High-responders Undergoing IVF
1 other identifier
interventional
113
1 country
1
Brief Summary
To compare the number of retrieved oocytes in the late start CF-alfa (day 4) versus standard CF-alfa protocols (day 2) in patients undergoing IVF. The primary analysis will be also performed in specific subgroups of patients: expected poor-responders, expected normal responders and expected hyper-responders
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2018
CompletedFirst Submitted
Initial submission to the registry
January 22, 2019
CompletedFirst Posted
Study publicly available on registry
January 25, 2019
CompletedJanuary 25, 2019
January 1, 2019
1.1 years
January 22, 2019
January 24, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
number of retrieved oocytes
To compare the number of retrieved oocytes in the late start CF-alfa (day 4) versus standard CF-alfa protocols (day 2) in patients undergoing IVF
1 year
Study Arms (6)
poor responders day 2
EXPERIMENTAL"poor responders" women stimulated with CF from day 2 of menstrual cycle
poor responders day 4
EXPERIMENTAL"poor responders" women stimulated with CF from day 4 of menstrual cycle
normal responders day 2
EXPERIMENTAL"normal responders" women stimulated with CF from day 2
normal responders day 4
EXPERIMENTAL"normal responders" women stimulated with CF from day 4
high responders day 2
EXPERIMENTAL"high responders" women stimulated with CF from day 2
high responders day 4
EXPERIMENTAL"high responders" women stimulated with CF from day 4
Interventions
late start (day 4) vs. corifollitropin-alfa standard start (day 2)
Eligibility Criteria
You may qualify if:
- aged 18- 43 years
- Male or tubal infertility with indication for IVF treatment
- No PCOS
- No previous IVF treatments in the past two months
- No history of previous Ovarian Hyperstimulation Syndrome (OHSS)
- No previous IVF cycle with more than 30 growing follicles ≥ 11 mm
- Antral Follicle Count (AFC) \<20
- No ovarian cyst nor malignant ovarian tumour, breast, uterus or central nervous cancer
You may not qualify if:
- AMH \< 0.2 ng/ml
- Età \> 43 anni
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Physiopathology of Reproduction and IVF Unit, S. Anna Hospital
Torino, 10126, Italy
Related Publications (1)
Revelli A, Gennarelli G, Sestero M, Canosa S, Carosso A, Salvagno F, Pittatore G, Filippini C, Benedetto C. A prospective randomized trial comparing corifollitropin-alpha late-start (day 4) versus standard administration (day 2) in expected poor, normal, and high responders undergoing controlled ovarian stimulation for IVF. J Assist Reprod Genet. 2020 May;37(5):1163-1170. doi: 10.1007/s10815-020-01742-5. Epub 2020 Mar 18.
PMID: 32185595DERIVED
MeSH Terms
Interventions
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
January 22, 2019
First Posted
January 25, 2019
Study Start
April 1, 2017
Primary Completion
April 30, 2018
Study Completion
December 31, 2018
Last Updated
January 25, 2019
Record last verified: 2019-01
Data Sharing
- IPD Sharing
- Will not share