Ovarian Stimulation Clinical Trial
Official title:
Lutropin Alfa (Luveris®) in Women at Risk of Poor Response Suppressed With Cetrorelix: an Exploratory Trial
Verified date | July 2018 |
Source | Merck KGaA |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Evaluate the effectiveness of adding lutropin alfa (recombinant human luteinizing hormone [r-hLH]) in the middle of the follicular phase compared to no addition, in infertile women at risk of poor response stimulated with follitropin alfa (recombinant Follicle-Stimulating Hormone [r-FSH]) under Gonadotropin Releasing Hormone (GnRH) antagonist in vitro fertilization (IVF)/intracytoplasmic sperm injection (ICSI), in the number and quality of oocytes, follicular development, fertilization oocyte, embryo quality, and pregnancy rate.
Status | Completed |
Enrollment | 58 |
Est. completion date | January 30, 2007 |
Est. primary completion date | January 30, 2007 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | N/A to 38 Years |
Eligibility |
Inclusion Criteria: - Participants who were at risk of poor response by at least one of the following criteria: a) <3 follicles in last cycle, or less than or equal to (</=) 2 metaphase II oocytes, or estradiol (E2) <600 pg/mL; b) Cancellation of previous cycle; c) Early follicular serum Follicle-Stimulating Hormone (FSH) >8.5 milli IU/L - 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 who had any clinically significant disease including known human immunodeficiency virus (HIV), hepatitis-B virus (HBV)/hepatitis-C virus (HCV) positivity - 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 |
Country | Name | City | State |
---|---|---|---|
Spain | Hospital Universitario de La Fe | Valencia |
Lead Sponsor | Collaborator |
---|---|
Merck KGaA |
Spain,
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,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Oocytes Retrieved | At the end of stimulation (Day 2 up to Day 8) | ||
Primary | Number of Follicles Greater Than (>) 14 Millimeter (mm) in Diameter | At the end of stimulation (Day 2 up to Day 8) | ||
Primary | Oocytes Recovery Rate | Oocytes recovery rate (oocytes per >14 mm follicle) is defined as number of oocytes retrieved divided by number of follicles >14 mm in diameter. | At the end of stimulation (Day 2 up to Day 8) | |
Secondary | Oocyte Nuclear Maturity Rate | Oocyte nuclear maturity rate (metaphase II oocytes per retrieved oocyte) is defined as number of metaphase II oocytes divided by total number of oocytes retrieved. | At the end of stimulation (Day 2 up to Day 8) | |
Secondary | Fertilization Rate | The fertilization rate (2 pronuclei [PN] fertilized oocytes per inseminated oocyte) was defined as number of 2 PN fertilized oocytes divided by number of inseminated oocytes. | Up to 35-45 days after administration of r-hCG (r-hCG administration = Day 2 to Day 8) | |
Secondary | Number of Embryos by Quality | Embryo quality was graded according to morphological classification of Veeck. Grade 1: even blastomeres with no fragmentation; Grade 2: even blastomeres with slight fragmentation (less than 20%); Grade 3: uneven size blastomeres with no fragmentation; Grade 4: even or uneven size blastomeres with moderate fragmentation (20-25%); and Grade 5: unrecognizable blastomeres with severe fragmentation (>50%). | Up to 35-45 days after administration of r-hCG (r-hCG administration = Day 2 to Day 8) | |
Secondary | Number of Embryos Transferred by In Vitro Fertilization (IVF) | Up to 35-45 days after administration of r-hCG (r-hCG administration = Day 2 to Day 8) | ||
Secondary | Number of Participants With Positive Pregnancy Test | The beta Human Chorionic Gonadotropin (beta-hCG) test was used as pregnancy test. | Up to 35-45 days after administration of r-hCG (r-hCG administration = Day 2 to Day 8) | |
Secondary | Number of Participants With Clinical Pregnancy | A clinical pregnancy is a pregnancy that is confirmed by both pregnancy test (beta-hCG test) and sonographic confirmation of a gestational sac or heartbeat (fetal sac). | Up to 35-45 days after administration of r-hCG (r-hCG administration = Day 2 to Day 8) | |
Secondary | Implementation Rate | Implementation rate (clinical pregnancy/embryo transferred) was defined as the number of clinical pregnancies divided by number of embryos transferred. | Up to 35-45 days after administration of r-hCG (r-hCG administration = Day 2 to Day 8) | |
Secondary | Plasma Level of Estradiol | At the time of r-hCG administration (any days between Day 2 to Day 8) | ||
Secondary | Endometrial Thickness | At the time of r-hCG administration (any days between Day 2 to Day 8) | ||
Secondary | Duration of Ovarian Stimulation | Duration of ovarian stimulation was defined as the time from start of study treatment to time of r-hCG administration. | Randomization to Day 8 | |
Secondary | rFSH Cumulative Dose | Randomization to Day 8 | ||
Secondary | Plasma Levels of LH | At the time of r-hCG administration (any days between Day 2 to Day 8) | ||
Secondary | Number of Participants in Whom At Least 1 Stimulation Cycle Was Cancelled | Randomization to Day 8 |
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