Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
58 participants
INTERVENTIONAL
2005-12-07
2007-01-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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r-FSH + r-hLH
Lutropin alfa (r-hLH) will be administered at a daily dose of 150 International Units (IU) from the presence of at least one follicle greater than (\>) 14 millimeter (mm) to complete ovarian stimulation. Follitropin alfa (r-FSH) will be administered at an initial dose of 225-450 IU per day (according to standard center practice); the dose will then be adjusted to ovarian response as assessed by ovarian ultrasound and/or serum estradiol. Participants will also receive analogous GnRH antagonist and natural progesterone, as per standard center practice. To complete follicular maturation and trigger ovulation, a single dose of 250 milligrams (mg) of recombinant Human Chorionic Gonadotropin (r-hCG) will be administered subcutaneously at 12 hours after the last injection of lutropin alfa and/or follitropin alfa and analogous GnRH antagonist.
r-FSH
r-FSH will be administered as specified in the arm description.
r-hLH
r-hLH will be administered as specified in the arm description.
Analogous GnRH antagonist
Analogous GnRH antagonist will be administered as specified in the arm description.
r-hCG
r-hCG will be administered as specified in the arm description.
Progesterone
Progesterone will be administered as specified in the arm description.
r-FSH
Follitropin alfa (r-FSH) will be administered at an initial dose of 225-450 IU per day (according to standard center practice); the dose will then be adjusted to ovarian response as assessed by ovarian ultrasound and/or serum estradiol. Participants will also receive analogous GnRH antagonist and natural progesterone, as per standard center practice. To complete follicular maturation and trigger ovulation, a single dose of 250 mg of r-hCG will be administered subcutaneously at 12 hours after the last injection of follitropin alfa and analogous GnRH antagonist.
r-FSH
r-FSH will be administered as specified in the arm description.
Analogous GnRH antagonist
Analogous GnRH antagonist will be administered as specified in the arm description.
r-hCG
r-hCG will be administered as specified in the arm description.
Progesterone
Progesterone will be administered as specified in the arm description.
Interventions
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r-FSH
r-FSH will be administered as specified in the arm description.
r-hLH
r-hLH will be administered as specified in the arm description.
Analogous GnRH antagonist
Analogous GnRH antagonist will be administered as specified in the arm description.
r-hCG
r-hCG will be administered as specified in the arm description.
Progesterone
Progesterone will be administered as specified in the arm description.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Participants with normal baseline luteinizing hormone and E2 levels
* Regular menstrual cycles of 25-35 days
* Presence of both ovaries and uterus able to withstand pregnancy
Exclusion Criteria
* Participants with more than 3 previous assisted reproductive techniques (ART) cycles
* Participants with polycystic ovaries or cyst of unknown etiology; unexplained gynecological bleeding
* Participants who had any contraindication to being pregnant
* Active substance abuse
* Participants who had simultaneously participated in another clinical drug trial
38 Years
FEMALE
No
Sponsors
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Merck KGaA, Darmstadt, Germany
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Responsible
Role: STUDY_DIRECTOR
Merck KGaA, Darmstadt, Germany
Locations
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Hospital Universitario de La Fe
Valencia, , Spain
Countries
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References
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M.J. Fernández Ramírez, A. Monzó, T. García-Gimeno, J.M. Rubio, V. Montañana, C. Duque, G. Herrero, A. Romeu. Role of LH administration during the follicullar phase in women with risk of low response in ovarian stimulation with FSH and cetrorelix for IVF, REVISTA IBEROAMERICANA DE FERTILIDAD, Vol. 23- nº 5 - Septiembre-Octubre 2006
Related Links
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Results publication in spanish language
Other Identifiers
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2005-002229-30
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
IMP26170 (INI25954)
Identifier Type: -
Identifier Source: org_study_id
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