A Study to Evaluate Safety and Efficacy of Recombinant Human Luteinizing Hormone (r-hLH) Compared With Urinary Human Chorionic Gonadotrophin (u-hCG) to Trigger Ovulation in Infertile Women

A Phase II, Single Center, Open, Randomized, Parallel Group, Dose Finding Study to Assess the Safety and Efficacy of Recombinant Human Luteinizing Hormone (r-hLH), Compared With Urinary Human Chorionic Gonadotrophin (u-hCG), in Inducing Ovulation in Infertile Women Undergoing Stimulation of Follicular Development With Recombinant Human Follicle Stimulating Hormone (Gonal F®).

This is a single center, open-label, randomized, parallel group, dose finding study to evaluate safety and efficacy of recombinant human luteinizing hormone (r-hLH, LHadi®), compared with urinary human chorionic gonadotrophin (u-hCG, Profasi®), both given subcutaneously, in inducing ovulation in infertile women undergoing stimulation of follicular growth with recombinant human follicle stimulating hormone (r-hFSH, Gonal-F®).

Inclusion Criteria:

• Infertile woman wishing to conceive and justifying ovarian stimulation treatment with gonadotrophins for in vivo conception

• Aged 20-40 years (inclusive)

• Male partner with acceptable semen analysis for intra-uterine insemination, according to center's standard practice

• Have the following hormone serum levels measured locally during early (Day 2-4) follicular phase (if menstruating) or at anytime (if not menstruating):

  • Follicle stimulating hormone (FSH) less than 12 international unit per liter (IU/L)
  • Prolactin (PRL) less than 800 milli international unit per liter (mIU/l)
  • Lutenizing hormone (LH), P4, Testosterone (T) and Dehydroepiandrosterone sulphate (DHEA-S) for documentation purposes

• At least one patent tube, as assessed with hysterosalpingography (HSG), ultrasound (U/S) or laparoscopy performed within 3 years prior to beginning r-hFSH treatment

• Uterine cavity without abnormalities which, in the Investigator's opinion, could impair embryo implantation or pregnancy evolution as assessed with HSG, hysteroscopy (HSC) or U/S performed within 3 years prior to beginning r-hFSH treatment

• Body mass index (BMI) greater than or equal to 18 and less than or equal to 35 kilogram per square meter (kg/m^2)

• Negative serum or urinary pregnancy test prior to beginning r-hFSH treatment

• Be willing and able to comply with the protocol for the duration of the study

• Have given written informed consent, prior to any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care

Exclusion Criteria:

• Any contraindication to being pregnant and/or carrying a pregnancy to term
• Clinically significant systemic disease (screening for Human Immunodeficiency Virus (HIV) and Hepatitis B and C surface antigens had to be performed to confirm eligibility, unless data obtained within one year prior to beginning r-hFSH treatment was available)
• Any medical condition which in the judgment of the Investigator's and sponsor may have interfered with the absorption, distribution, metabolism or excretion of the study drug
• Persistent ovarian cyst with a mean diameter larger than 20 mm or ovarian endometrioma, as assessed with U/S performed prior to beginning r-hFSH treatment
• Severe endometriosis (American Fertility Society Classification Stage III or IV)
• World health organization (WHO) Group I anovulation
• Pelvic inflammatory disease within 1 year prior to beginning r-hFSH treatment
• Treatment with clomiphene citrate or gonadotrophins within 1 month prior to beginning r-hFSH treatment
• Abnormal undiagnosed gynecological bleeding
• Known allergy or hypersensitivity to human gonadotrophins preparations
• Known or current substance abuse
• Previous participation in this study or simultaneous participation in another clinical trial