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

Fertility Disorders Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03816670
• Other study ID #: IIS#53736
• Status: Completed
• Phase: N/A
• Start date: April 1, 2017
• Est. completion date: December 31, 2018

Study information

• Verified date: January 2019
• Source: University of Turin, Italy
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 113
• Est. completion date: December 31, 2018
• Est. primary completion date: April 30, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 43 Years

Eligibility

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

Related Conditions & MeSH terms

• Fertility Disorders

Intervention

Drug:
• Corifollitropin Alfa
late start (day 4) vs. corifollitropin-alfa standard start (day 2)

Locations

Country	Name	City	State
Italy	Physiopathology of Reproduction and IVF Unit, S. Anna Hospital	Torino

Sponsors (1)

Lead Sponsor	Collaborator
University of Turin, Italy

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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