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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02254928
Other study ID # MANCOR
Secondary ID
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


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
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