Lutropin Alfa in Women at Risk of Poor Response

NCT01112358 | Completed Phase 2 Results

• 2 other identifiers: IMP26170 (INI25954)2005-002229-30
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

Ovarian Stimulation

Keywords

Lutropin alfa; Fertilization in vitro; Intracytoplasmic sperm injection; Reproductive techniques, assisted

Outcome Measures

Primary Outcomes (3)

• Number of Oocytes Retrieved

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

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

  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.

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

Secondary Outcomes (13)

• Oocyte Nuclear Maturity Rate

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

• Fertilization Rate

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

• Number of Embryos by Quality

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

• 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)

• Number of Participants With Positive Pregnancy Test

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

Study Arms (2)

r-FSH + r-hLH

EXPERIMENTAL

Lutropin alfa (r-hLH) will be administered at a daily dose of 150 International Units (IU) from the presence of at least one follicle greater than (\>) 14 millimeter (mm) to complete ovarian stimulation. Follitropin alfa (r-FSH) will be administered at an initial dose of 225-450 IU per day (according to standard center practice); the dose will then be adjusted to ovarian response as assessed by ovarian ultrasound and/or serum estradiol. Participants will also receive analogous GnRH antagonist and natural progesterone, as per standard center practice. To complete follicular maturation and trigger ovulation, a single dose of 250 milligrams (mg) of recombinant Human Chorionic Gonadotropin (r-hCG) will be administered subcutaneously at 12 hours after the last injection of lutropin alfa and/or follitropin alfa and analogous GnRH antagonist.

Drug: r-FSH; Drug: r-hLH; Drug: Analogous GnRH antagonist; Drug: r-hCG; Drug: Progesterone

r-FSH

ACTIVE COMPARATOR

Follitropin alfa (r-FSH) will be administered at an initial dose of 225-450 IU per day (according to standard center practice); the dose will then be adjusted to ovarian response as assessed by ovarian ultrasound and/or serum estradiol. Participants will also receive analogous GnRH antagonist and natural progesterone, as per standard center practice. To complete follicular maturation and trigger ovulation, a single dose of 250 mg of r-hCG will be administered subcutaneously at 12 hours after the last injection of follitropin alfa and analogous GnRH antagonist.

Drug: r-FSH; Drug: Analogous GnRH antagonist; Drug: r-hCG; Drug: Progesterone

Interventions

r-FSH DRUG

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

Also known as: Follitropin alfa; Gonal-F®

r-FSH; r-FSH + r-hLH

r-hLH DRUG

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

Also known as: Lutropin alfa; Luveris®

r-FSH + r-hLH

Analogous GnRH antagonist DRUG

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

Also known as: Cetrotide®

r-FSH; r-FSH + r-hLH

r-hCG DRUG

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

r-FSH; r-FSH + r-hLH

Progesterone DRUG

Progesterone will be administered as specified in the arm description.

r-FSH; r-FSH + r-hLH

Eligibility Criteria

• Age: Up to 38 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck KGaA, Darmstadt, Germany: lead

Study Sites (1)

Hospital Universitario de La Fe

Valencia, Spain

Location

Related 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, REVISTA IBEROAMERICANA DE FERTILIDAD, Vol. 23- nº 5 - Septiembre-Octubre 2006

  RESULT

Related Links

• Results publication in spanish language

MeSH Terms

Conditions

Helping Behavior

Interventions

follitropin alfa; Luteinizing Hormone, beta Subunit; cetrorelix; Progesterone

Condition Hierarchy (Ancestors)

Social Behavior; Behavior

Intervention Hierarchy (Ancestors)

Luteinizing Hormone; Gonadotropins, Pituitary; Gonadotropins; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pituitary Hormones, Anterior; Pituitary Hormones; Peptides; Amino Acids, Peptides, and Proteins; Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Corpus Luteum Hormones; Gonadal Hormones; Progesterone Congeners; Gonadal Steroid Hormones

Results Point of Contact

• Title: Merck KGaA Communication Center,
• Organization: Merck Healthcare, a business of Merck KGaA, Darmstadt, Germany

service@merckgroup.com

496151725200

Study Officials

• Medical Responsible

  Merck KGaA, Darmstadt, Germany

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2010
• First Posted: April 28, 2010
• Study Start: December 7, 2005
• Primary Completion: January 30, 2007
• Study Completion: January 30, 2007
• Last Updated: August 28, 2018
• Results First Posted: July 30, 2018

Record last verified: 2018-07

Locations

ES (1)