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Prospective Randomized Trial Comparing Corifollitropin-alfa Late Start vs. Corifollitropin-alfa Standard Start in Expected Poor, Normal and High-responders Undergoing IVF

Prospective Randomized Trial Comparing Corifollitropin-alfa Late Start (Day 4) vs. Corifollitropin-alfa Standard Start (Day 2) in Expected Poor, Normal and High-responders Undergoing IVF/ICSI

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03816670
Enrollment
113
Registered
2019-01-25
Start date
2017-04-01
Completion date
2018-12-31
Last updated
2019-01-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fertility Disorders

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

Detailed description

The investigators hypothesize that: 1. CF-alfa late start (day 4) will show comparable efficacy in terms of number of retrieved oocytes versus standard CF-alfa (day 2) protocol. In certain groups of patients, CF-alfa late start might show differences in terms of efficacy such as in poor-responder patients. 2. CF-alfa late start (day 4) will obtain similar results in terms of vital pregnancy rates with a similar safety profile with respect to COS performed using CF-alfa standard administration (day 2) in expected normal, poor, or high responders. 3. Oocytes and embryos obtained using CF-alfa late start will have comparable morphological features and development potential than those obtained with CF-alfa standard. 4. The patients' satisfaction will possibly be higher using CF-alfa late start than with CF-alfa standard expecially in those patients who will not have the need to add further daily recFSH injections

Interventions

DRUGCorifollitropin Alfa

late start (day 4) vs. corifollitropin-alfa standard start (day 2)

Sponsors

University of Turin, Italy
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 43 Years
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* AMH \< 0.2 ng/ml * Età \> 43 anni

Design outcomes

Primary

MeasureTime frameDescription
number of retrieved oocytes1 yearTo 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

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 28, 2026