Lutropin Alfa in Women at Risk of Poor Response

Merck KGaA, Darmstadt, Germany58 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Ovarian Stimulation

Interventions

r-FSHDRUG

r-FSH will be administered as specified in the arm description.

r-hLHDRUG

r-hLH will be administered as specified in the arm description.

Analogous GnRH antagonistDRUG

Analogous GnRH antagonist will be administered as specified in the arm description.

Eligibility

Sex: FEMALEMax age: 38 Years

Medical Language ↔ Plain English

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

Locations (1)

Hospital Universitario de La Fe

Valencia, Spain

Outcomes

Primary Outcomes

Number of Oocytes Retrieved

Time frame: At the end of stimulation (Day 2 up to Day 8)

Number of Follicles Greater Than (>) 14 Millimeter (mm) in Diameter

Time frame: At the end of stimulation (Day 2 up to Day 8)

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.

Time frame: At the end of stimulation (Day 2 up to Day 8)

Secondary Outcomes

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.

Time frame: At the end of stimulation (Day 2 up to Day 8)

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.

Time frame: Up to 35-45 days after administration of r-hCG (r-hCG administration = Day 2 to Day 8)

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%).

Time frame: Up to 35-45 days after administration of r-hCG (r-hCG administration = Day 2 to Day 8)

Data from ClinicalTrials.gov

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