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Completed

NCT Number: NCT03816670

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

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

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Key information

Conditions

Age range

18 year–43 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Physiopathology of Reproduction and IVF Unit, S. Anna Hospital

Torino, 10126, Italy

About this study

The investigators hypothesize that:

  • 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.
  • 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.
  • Oocytes and embryos obtained using CF-alfa late start will have comparable morphological features and development potential than those obtained with CF-alfa standard.
  • 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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Corifollitropin alfa

Drug

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

Primary outcomes

  1. number of retrieved oocytes

    Time frame: 1 year

    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

Sponsors and collaborators

Lead sponsor

University of Turin, Italy

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jan 25, 2019
Registry last updated
Jan 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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