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
- Registration Number
- NCT01735422
- Lead Sponsor
- Merck KGaA, Darmstadt, Germany
- Brief Summary
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®).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 67
-
Infertile woman wishing to conceive and justifying ovarian stimulation treatment with gonadotrophins for in vivo conception
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Aged 20-40 years (inclusive)
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Male partner with acceptable semen analysis for intra-uterine insemination, according to center's standard practice
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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
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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)
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Negative serum or urinary pregnancy test prior to beginning r-hFSH treatment
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Be willing and able to comply with the protocol for the duration of the study
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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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description r-hLH (825 International Units [IU]) r-hFSH - r-hLH (2750 IU) r-hFSH - r-hLH (5500 IU) r-hFSH - r-hLH (22000 IU) r-hFSH - r-hLH (11000 IU) r-hFSH - u-hCG (5000 IU) r-hFSH - u-hCG (5000 IU) u-hCG - r-hLH (825 International Units [IU]) r-hLH - r-hLH (2750 IU) r-hLH - r-hLH (11000 IU) r-hLH - r-hLH (22000 IU) r-hLH - r-hLH (5500 IU) r-hLH -
- Primary Outcome Measures
Name Time Method Ovulation rate Day 4 post r-hLH/u-hCG day (end of stimulation cycle [approximately 28 days]) Ratio of ruptured follicles per follicle with diameter greater than or equal to (>=) 15 millimeter (mm) Day 4 post r-hLH/u-hCG day (end of stimulation cycle [approximately 28 days]) Number of follicles with diameter greater than or equal to (>=) 11 millimeter (mm) Day 4 post r-hLH/u-hCG day (end of stimulation cycle [approximately 28 days]) Ratio of ruptured follicles per follicle with diameter greater than or equal to (>=) 11 millimeter (mm) Day 4 post r-hLH/u-hCG day (end of stimulation cycle [approximately 28 days])
- Secondary Outcome Measures
Name Time Method Serum estradiol (E2) levels Day 1, 2 and 6-9 post r-hLH/u-hCG day (end of stimulation cycle [approximately 28 days]) Number of participants with biochemical pregnancy Day 25-30 post r-hLH/u-hCG day (end of stimulation cycle [approximately 28 days]) Serum total renin levels Day 1, 2 and 6-9 post r-hLH/u-hCG day (end of stimulation cycle [approximately 28 days]) Serum vascular endothelial growth factor (VEGF) levels Day 1, 2 and 6-9 post r-hLH/u-hCG day (end of stimulation cycle [approximately 28 days]) Serum androstenedione levels Day 1, 2 and 6-9 post r-hLH/u-hCG day (end of stimulation cycle [approximately 28 days]) Endometrial thickness Day 0, 1, 2, 3, 4 and 6-9 post r-hLH/u-hCG day (end of stimulation cycle [approximately 28 days]) Percentage of participants with mono-follicular ovulation Day 4 post r-hLH/u-hCG day (end of stimulation cycle [approximately 28 days]) Number of participants with clinical pregnancy Day 25-30 post r-hLH/u-hCG day (end of stimulation cycle [approximately 28 days]) Serum progesterone (P4) levels Day 1, 2 and 6-9 post r-hLH/u-hCG day (end of stimulation cycle [approximately 28 days])
Trial Locations
- Locations (1)
Royal University Hospital
🇨🇦Saskatoon, Saskatchewan, Canada