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

Infertility Clinical Trial

— MANCOR  

Official title:

Comparative Study Between the Use of Corifollitropin Alfa and Daily Recombinant FSH in the Controlled Ovarian Stimulation of Poor Responders

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02254928
• Other study ID #: MANCOR
• Status: Terminated
• Phase: Phase 4
• First received: September 25, 2014
• Last updated: January 15, 2016
• Start date: September 2014
• Est. completion date: November 2015

Study information

• Verified date: January 2016
• Source: IVI Sevilla
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Agencia Española del Medicamento y Productos Sanitarios
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 26
• Est. completion date: November 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infertility

Intervention

Drug:
• Corifollitropin alfa
One dose of 150 µg of corifollitropin alfa will be administered at day 1 of stimulation. Stimulation will be continued with 250-300 IU/day of rFSH from day 8 forward.

Locations

Country	Name	City	State
Spain	IVI Barcelona	Barcelona
Spain	IVI Madrid	Madrid
Spain	IVI Sevilla	Seville
Spain	IVI Valencia	Valencia

Sponsors (4)

Lead Sponsor	Collaborator
IVI Sevilla	Instituto Valenciano de Infertilidad, IVI VALENCIA, IVI Barcelona, IVI Madrid

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of mature oocytes (metaphase II)	Number of mature oocytes (metaphase II) obtained after the follicle puncture	1 year	No
Secondary	Total number of oocytes	Total number of oocytes obtained after the follicle puncture	1 year	No
Secondary	Symptoms associated with the ovarian stimulation protocol	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.	1 year	Yes
Secondary	Patient perception of the stimulation treatment	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.	1 year	Yes
Secondary	Length of the stimulation treatment	Days of stimulation treatment	1 year	No
Secondary	Number of subcutaneous injections	Number of subcutaneous injections of gonadotropins (corifollitropin alfa, rFSH and HMG)	1 year	No