Lutropin Alfa in Women at Risk of Poor Response

Merck KGaA (EMD Serono)

Status and phase: Completed; Phase 2

Conditions: Ovarian Stimulation

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT01112358

2005-002229-30 (EudraCT Number)

IMP26170 (INI25954)

Details and patient eligibility

About

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.

Enrollment: 58 patients

Sex: Female

Ages: Under 38 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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58 participants in 2 patient groups

r-FSH + r-hLH

Experimental group

Description:

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.

Treatment:

Drug: Analogous GnRH antagonist

Drug: r-FSH

Drug: Progesterone

Drug: r-hLH

Drug: r-hCG

r-FSH

Active Comparator group

Description:

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.

Treatment:

Drug: Analogous GnRH antagonist

Drug: r-FSH

Drug: Progesterone

Drug: r-hCG