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

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

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02254928

Acronym

MANCOR

Enrollment

Registered

2014-10-02

Start date

2014-09-30

Completion date

2015-11-30

Last updated

2016-01-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertility

Keywords

poor ovarian response, controlled ovarian stimulation, randomised clinical trial, corifollitropin alfa, recombinant follicle-stimulating hormone (rFSH), human menopausal gonadotropin (HMG)

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.

Interventions

DRUGCorifollitropin 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.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame	Description
Number of mature oocytes (metaphase II)	1 year	Number of mature oocytes (metaphase II) obtained after the follicle puncture

Secondary

Measure	Time frame	Description
Total number of oocytes	1 year	Total number of oocytes obtained after the follicle puncture
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.
Length of the stimulation treatment	1 year	Days of stimulation treatment
Number of subcutaneous injections	1 year	Number of subcutaneous injections of gonadotropins (corifollitropin alfa, rFSH and HMG)

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026