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Lutropin Alfa in Women at Risk of Poor Response

Merck KGaA (EMD Serono) logo

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)

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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