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Completed

NCT Number: NCT01112358

Lutropin Alfa in Women at Risk of Poor Response

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.

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Key information

Conditions

OVARIAN STIMULATION Behavior Helping Behavior Social Behavior

Age range

Up to 38 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Hospital Universitario de La Fe

Valencia, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

r-FSH

Drug

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

Other names: Follitropin alfa; Gonal-F®

r-hLH

Drug

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

Other names: Lutropin alfa; Luveris®

Analogous GnRH antagonist

Drug

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

Other names: Cetrotide®

r-hCG

Drug

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

Progesterone

Drug

Progesterone will be administered as specified in the arm description.

Primary outcomes

  1. Number of Oocytes Retrieved

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

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

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

  3. Oocytes Recovery Rate

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

    Oocytes recovery rate (oocytes per >14 mm follicle) is defined as number of oocytes retrieved divided by number of follicles >14 mm in diameter.

Secondary outcomes

  1. Oocyte Nuclear Maturity Rate

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

    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.

  2. Fertilization Rate

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

    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.

  3. Number of Embryos by Quality

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

    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%).

  4. Number of Embryos Transferred by In Vitro Fertilization (IVF)

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

  5. Number of Participants With Positive Pregnancy Test

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

    The beta Human Chorionic Gonadotropin (beta-hCG) test was used as pregnancy test.

  6. Number of Participants With Clinical Pregnancy

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

    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).

  7. Implementation Rate

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

    Implementation rate (clinical pregnancy/embryo transferred) was defined as the number of clinical pregnancies divided by number of embryos transferred.

  8. Plasma Level of Estradiol

    Time frame: At the time of r-hCG administration (any days between Day 2 to Day 8)

  9. Endometrial Thickness

    Time frame: At the time of r-hCG administration (any days between Day 2 to Day 8)

  10. Duration of Ovarian Stimulation

    Time frame: Randomization to Day 8

    Duration of ovarian stimulation was defined as the time from start of study treatment to time of r-hCG administration.

  11. rFSH Cumulative Dose

    Time frame: Randomization to Day 8

  12. Plasma Levels of LH

    Time frame: At the time of r-hCG administration (any days between Day 2 to Day 8)

  13. Number of Participants in Whom At Least 1 Stimulation Cycle Was Cancelled

    Time frame: Randomization to Day 8

Sponsors and collaborators

Lead sponsor

Merck KGaA, Darmstadt, Germany

Industry

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2007
Study completion
2007
First posted
Apr 28, 2010
Registry last updated
Aug 28, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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