Corifollitropin Alfa Versus Daily rFSH in the Controlled Ovarian Stimulation of Poor Responders

Phase 4

Terminated

• Conditions: Infertility
• Interventions: Drug: Corifollitropin alfa

• Registration Number: NCT02254928
• Lead Sponsor: IVI Sevilla

Brief Summary

A randomised, crossover, multicentre, national, clinical trial comparing the efficacy of corifollitropin alfa versus daily recombinant FSH and HMG in the controlled ovarian stimulation of women with a poor ovarian response undergoing IVF treatments. The main objective of this study is comparing the number of oocytes obtained after the follicle puncture when using each of these two stimulation protocols. Only poor responders according to the Bologna criteria will be recruited for this trial. All participants will undergo two stimulation cycles to obtain and accumulate oocytes by vitrification. One of the cycles will be done with the corifollitropin alfa protocol and the other with daily rFSH and HMG, the order of application of these protocols will be randomised (crossover clinical trial) in each patient.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2014-09-25
• Study First Submitted QC: 2014-09-29
• Study First Posted: 2014-10-02
• Primary Completion: 2015-07
• Study Completion: 2015-11
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-15
• Last Update Posted: 2016-01-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 26

Inclusion Criteria

• Advanced maternal age (≥40 years)
• A previous poor ovarian response (≤3 oocytes with a conventional stimulation protocol)
• An abnormal ovarian reserve test (i.e. antral follicle count <5-7 follicles or anti-mullerian hormone level <0.5-1.1 ng/ml)

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group 2	Corifollitropin alfa	First stimulation cycle with rFSH and HMG (active comparator) Second stimulation cycle with corifollitropin alfa (experimental)
Group 1	Corifollitropin alfa	First stimulation cycle with corifollitropin alfa (experimental) Second stimulation cycle with rFSH and HMG (active comparator)

Primary Outcome Measures

Name	Time	Method
Number of mature oocytes (metaphase II)	1 year	Number of mature oocytes (metaphase II) obtained after the follicle puncture

Secondary Outcome Measures

Name	Time	Method
Total number of oocytes	1 year	Total number of oocytes obtained after the follicle puncture
Number of subcutaneous injections	1 year	Number of subcutaneous injections of gonadotropins (corifollitropin alfa, rFSH and HMG)
Length of the stimulation treatment	1 year	Days of stimulation treatment
Symptoms associated with the ovarian stimulation protocol	1 year	Patients will evaluate their symptoms using a questionnaire. They will score the intensity (from 1 to 10) of each of the following symptoms: pelvic pain, headache, mood swings, nausea, tiredness, breast pain.
Patient perception of the stimulation treatment	1 year	Patients will evaluate how they have perceived the stimulation treatment using a questionnaire. They will score their comfort (from 1 to 10) with the following aspects of the treatment: treatment administration, number of injections and treatment length.

Trial Locations

Locations (4)

IVI Barcelona; 🇪🇸 Barcelona, Spain

IVI Madrid; 🇪🇸 Madrid, Spain

IVI Sevilla; 🇪🇸 Seville, Spain

IVI Valencia; 🇪🇸 Valencia, Spain