Lutropin Alfa in Women at Risk of Poor Response

Ovarian Stimulation Clinical Trial

Official title:

Lutropin Alfa (Luveris®) in Women at Risk of Poor Response Suppressed With Cetrorelix: an Exploratory Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01112358
• Other study ID #: IMP26170 (INI25954)
• Secondary ID: 2005-002229-30
• Status: Completed
• Phase: Phase 2
• Start date: December 7, 2005
• Est. completion date: January 30, 2007

Study information

• Verified date: July 2018
• Source: Merck KGaA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Ovarian Stimulation

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
Spain	Hospital Universitario de La Fe	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
Merck KGaA

Country where clinical trial is conducted

Spain, 

References & Publications (1)

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,

Outcome

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

External Links

•   Results publication in spanish language