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

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

Study Overview

• Status: Completed
• Conditions: Fertility Disorders
• Intervention / Treatment: Drug: Corifollitropin Alfa

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

• Study Type: Interventional
• Enrollment (Actual): 113
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Torino, Italy, 10126
    • Physiopathology of Reproduction and IVF Unit, S. Anna Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 43 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: poor responders day 2; "poor responders" women stimulated with CF from day 2 of menstrual cycle	Drug: Corifollitropin Alfa; late start (day 4) vs. corifollitropin-alfa standard start (day 2)
Experimental: poor responders day 4; "poor responders" women stimulated with CF from day 4 of menstrual cycle	Drug: Corifollitropin Alfa; late start (day 4) vs. corifollitropin-alfa standard start (day 2)
Experimental: normal responders day 2; "normal responders" women stimulated with CF from day 2	Drug: Corifollitropin Alfa; late start (day 4) vs. corifollitropin-alfa standard start (day 2)
Experimental: normal responders day 4; "normal responders" women stimulated with CF from day 4	Drug: Corifollitropin Alfa; late start (day 4) vs. corifollitropin-alfa standard start (day 2)
Experimental: high responders day 2; "high responders" women stimulated with CF from day 2	Drug: Corifollitropin Alfa; late start (day 4) vs. corifollitropin-alfa standard start (day 2)
Experimental: high responders day 4; "high responders" women stimulated with CF from day 4	Drug: Corifollitropin Alfa; late start (day 4) vs. corifollitropin-alfa standard start (day 2)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Turin, Italy

Publications and helpful links

General Publications

• 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. Erratum In: J Assist Reprod Genet. 2020 May 22;:

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2017
• Primary Completion (Actual): April 30, 2018
• Study Completion (Actual): December 31, 2018

Study Registration Dates

• First Submitted: January 22, 2019
• First Submitted That Met QC Criteria: January 24, 2019
• First Posted (Actual): January 25, 2019

Study Record Updates

• Last Update Posted (Actual): January 25, 2019
• Last Update Submitted That Met QC Criteria: January 24, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: IIS#53736

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No