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

I

IVI Sevilla

Status and phase

Terminated
Phase 4

Conditions

Infertility

Treatments

Drug: Corifollitropin alfa

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Enrollment

26 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

26 participants in 2 patient groups

Group 1
Other group
Description:
First stimulation cycle with corifollitropin alfa (experimental) Second stimulation cycle with rFSH and HMG (active comparator)
Treatment:
Drug: Corifollitropin alfa
Group 2
Other group
Description:
First stimulation cycle with rFSH and HMG (active comparator) Second stimulation cycle with corifollitropin alfa (experimental)
Treatment:
Drug: Corifollitropin alfa

Trial contacts and locations

4

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Data sourced from clinicaltrials.gov

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