Reproductive Techniques, Assisted Clinical Trial
— Luveris in ARTOfficial title:
A Phase III, Multicentric, Randomized, Open, Comparative Study to Evaluate if the Addition of Recombinant Human Luteinising Hormone [r-hLH (Luveris®)] to Follicle Stimulating Hormone (FSH) From Day 8 of Ovarian Stimulation is Able to Decrease Total FSH Dose and to Improve Cycle Outcome in Infertile Women Undergoing Assisted Reproduction Technology (ART), Who Required High FSH Dose in a Previous Cycle
Verified date | December 2013 |
Source | Merck KGaA |
Contact | n/a |
Is FDA regulated | No |
Health authority | Italy: Ethics Committee |
Study type | Interventional |
The present study was designed to investigate, in hyporesponder subjects, that required in a previous assisted reproductive technologies (ART) cycle follicle stimulating hormone (FSH) >3500 International Unit (IU), the possibility to decrease through recombinant human luteinizing hormone (r-hLH) supplementation, the FSH amount per oocytes retrieved and in the mean time to improve the overall cycle outcome.
Status | Terminated |
Enrollment | 133 |
Est. completion date | April 2009 |
Est. primary completion date | April 2009 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 40 Years |
Eligibility |
Inclusion Criteria: - Pre-menopausal infertile woman, aged 18 to 40 years inclusive, who wishes to conceive - Regular, spontaneous menstrual cycle of 25-35 days - Body mass index (BMI) = 28 - FSH = 10 IU/L (follicular phase, days 2-5) - Prolactin (PRL) within the normal ranges - Evidence of both ovaries by ultrasound scan - Women undergoing IVF-Embryo Transfer (ET) or ICSI, down regulated with Gonadotropin releasing hormone analogues (GnRHa) (daily dose) under controlled ovarian hyperstimulation (COH) with FSH - Washout > 90 days from last dose of clomiphene or gonadotrophin, before ongoing COH cycle - Only one previous IVF-ET or ICSI cycle (in the last 9 months preceding the ongoing COH cycle) resulted in a hypo-response properly documented (from 6 to 12 oocytes with a total FSH dose = 4000 IU) - Negative pregnancy hCG test (urine or blood sample) before the ongoing COH cycles - Willing and able to comply with the protocol for the duration of the study - Written informed consent before applying any procedure related to the study protocol, which is not part of routine medical care, with the understanding that consent may be withdrawn by the subject at any time, without prejudice on their future medical care Exclusion Criteria: - Oligo/Anovulatory cycles (World Health Organization [WHO] I and II) - Male partner azoospermia (assessed within the last 12 months) - Follicular phase (day 2-5) FSH > 10 IU/L even if only once observed in the medical history - Abnormal cervical cytology (assessed within the last 12 months) - History of unexplained gynecologic hemorrhage - Any contraindication to pregnancy - Known allergy to gonadotrophin - Any clinically important systemic disease (e.g. insulin-dependent diabetes mellitus, epilepsy, serious migraine, intermittent purpura, hepatic, renal or cardiovascular disease, serious corticoid-dependent asthma) which constitutes a contraindication to gonadotropin use - Any medical condition which, according to the investigator's judgement, may affect the absorption, distribution, metabolism or excretion of the drug. In case of doubt, inclusion of the subject in question should be discussed with the Medical Responsible of Serono - Known Human Immunodeficiency Virus (HIV) positivity - Any substance abuse or history of drugs or alcohol abuse within the past 5 years - Prior inclusion in the present study or simultaneous inclusion in a clinical study of another drug - Refusal or inability to comply with the protocol |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Italy | Merck Serono S.p.A. | Roma |
Lead Sponsor | Collaborator |
---|---|
Merck KGaA | Merck Serono S.P.A., Italy |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Total Dose of Follicular Stimulating Hormone (FSH) for Retrieved Oocytes | Baseline (Stimulation day 8 [S8]) until hCG day | No | |
Secondary | Mean Total Follicle Stimulating Hormone (FSH) and Recombinant Human Luteinizing Hormone (r-hLH) Dose | Baseline (S8) until hCG day | No | |
Secondary | Mean Number of Ovarian Stimulation Days | Baseline (S8) until hCG day | No | |
Secondary | Change From Baseline in Oestradiol (E2) Levels at Human Choriogonadotropin (hCG) Day | Baseline (S8) and hCG day | No | |
Secondary | Mean Total Number of Retrieved Oocytes | Mean number of oocytes retrieved on the day of ovum pick up (OPU) was counted. Oocyte retrieval is a technique used in in-vitro fertilization in order to remove oocytes from the ovary of the female, enabling fertilization outside the body. | 34-36 hours post-hCG (OPU) | No |
Secondary | Mean Number of Mature Oocytes (Metaphase II) | Mean number of metaphase II oocytes was counted for participants undergoing ovum pick up for IntraCytoplasmic Sperm Injection (ICSI). ICSI is a procedure in which a single spermatozoon is injected into the oocyte cytoplasm. Metaphase II stage of the oocyte was classified as the time at which the first polar body was observed microscopically. Metaphase II oocytes are a sub-group of the total number of oocytes. | 34-36 hours post-hCG (OPU) | No |
Secondary | Fertilization Rate | Fertilization rate was measured as the ratio between number of fertilized oocytes and number of inseminated oocytes (maximum 3). | 12-18 day post-hCG and/or Week 7 | No |
Secondary | Number of Obtained Embryos | Total number of obtained embryos with maximum 3 inseminated oocytes was calculated. | Day 3 post-hCG (Embryo transfer [ET]) | No |
Secondary | Number of Transferred Embryos | Embryo transfer is the procedure in which one or more embryos are placed in the uterus or Fallopian tube. | Day 3 post-hCG (ET) | No |
Secondary | Percentage of Participants With Pregnancy | 12-18 day post-hCG and/or Week 7 | No | |
Secondary | Percentage of Participants With Clinical Pregnancy | Clinical pregnancy is defined as pregnancy diagnosed by ultrasonographic visualization of one or more gestational sacs or definitive clinical signs of pregnancy. It includes ectopic pregnancy. | 12-18 day post-hCG and/or Week 7 | No |
Secondary | Percentage of Participants With Implantation | Implantation is the attachment and subsequent penetration by the zona-free blastocyst (usually in the endometrium) that starts five to seven days after fertilization. | 12-18 day post-hCG and/or Week 7 | No |
Secondary | Number of Participants With Ovarian Hyper Stimulation Syndrome (OHSS) | OHSS is an exaggerated systemic response to ovarian stimulation characterized by a wide spectrum of clinical and laboratory manifestations. It is classified as mild, moderate or severe according to the degree of abdominal distention, ovarian enlargement and respiratory, haemodynamic and metabolic complications. | Baseline (S8) until 12-18 day post-hCG and/or Week 7 | Yes |
Secondary | Number of Cycles Cancelled Due to Risk of OHSS | OHSS is an exaggerated systemic response to ovarian stimulation characterized by a wide spectrum of clinical and laboratory manifestations. It is classified as mild, moderate or severe according to the degree of abdominal distention, ovarian enlargement and respiratory, haemodynamic and metabolic complications. | Baseline (S8) until 12-18 day post-hCG and/or Week 7 | Yes |
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