Clinical trial NCT01112358: Lutropin Alfa in Women at Risk of Poor Response
Official title: Lutropin Alfa (Luveris®) in Women at Risk of Poor Response Suppressed With Cetrorelix: an Exploratory Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ovarian Stimulation
Keywords: Lutropin alfa
Fertilization in vitro
Intracytoplasmic sperm injection
Reproductive techniques, assisted
Lead sponsor: Merck KGaA, Darmstadt, Germany
Sponsor class: INDUSTRY
First posted: 2010-04-28
Enrollment: 58
Sex: FEMALE
Maximum age (years): 38
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of Oocytes Retrieved
timeFrame: At the end of stimulation (Day 2 up to Day 8)
measure: Number of Follicles Greater Than (>) 14 Millimeter (mm) in Diameter
timeFrame: At the end of stimulation (Day 2 up to Day 8)
measure: Oocytes Recovery Rate
timeFrame: At the end of stimulation (Day 2 up to Day 8)
Secondary outcomes:
measure: Oocyte Nuclear Maturity Rate
timeFrame: At the end of stimulation (Day 2 up to Day 8)
measure: Fertilization Rate
timeFrame: Up to 35-45 days after administration of r-hCG (r-hCG administration = Day 2 to Day 8)
measure: Number of Embryos by Quality
timeFrame: Up to 35-45 days after administration of r-hCG (r-hCG administration = Day 2 to Day 8)
measure: Number of Embryos Transferred by In Vitro Fertilization (IVF)
timeFrame: Up to 35-45 days after administration of r-hCG (r-hCG administration = Day 2 to Day 8)
measure: Number of Participants With Positive Pregnancy Test
timeFrame: Up to 35-45 days after administration of r-hCG (r-hCG administration = Day 2 to Day 8)
measure: Number of Participants With Clinical Pregnancy
timeFrame: Up to 35-45 days after administration of r-hCG (r-hCG administration = Day 2 to Day 8)
measure: Implementation Rate
timeFrame: Up to 35-45 days after administration of r-hCG (r-hCG administration = Day 2 to Day 8)
measure: Plasma Level of Estradiol
timeFrame: At the time of r-hCG administration (any days between Day 2 to Day 8)
measure: Endometrial Thickness
timeFrame: At the time of r-hCG administration (any days between Day 2 to Day 8)
measure: Duration of Ovarian Stimulation
timeFrame: Randomization to Day 8
measure: rFSH Cumulative Dose
timeFrame: Randomization to Day 8
measure: Plasma Levels of LH
timeFrame: At the time of r-hCG administration (any days between Day 2 to Day 8)
measure: Number of Participants in Whom At Least 1 Stimulation Cycle Was Cancelled
timeFrame: Randomization to Day 8
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Hospital Universitario de La Fe
Study officials:
affiliation: Merck KGaA, Darmstadt, Germany
name: Medical Responsible
role: STUDY_DIRECTOR
References:
citation: 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