In vitro fertilization include controlled ovarian stimulation (COS), where follicles are stimulated to full maturity. One of the main problems of the IVF treatment is still to some patients develop a very large number of follicles, and others only a few. A large number of follicles (eggs) increases the risk of ovarian hyperstimulation syndrome (OHSS), while few follicles (eggs) reduces the chance of pregnancy. MedDRA version: 14.1 Level: LLT Classification code 10021930 Term: Infertility
Conditions
Interventions
Trade Name: Puregon
Product Name: Puregon
Product Code: EU/1/96/008/018
Pharmaceutical Form: Injection
Trade Name: Elonva
Product Name: Elonva
Product Code: EU/1/09/609/001
Pharmaceutical Form: Injec
Sponsors
Fertility Clinic, Copenhagen University Hospital, Rigshospitalet
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Women with evidence of COS a view IVFeller ICSI - First treatment with IVF / ICSI in the department - Age between 25-38 years; - AMH is between 5-50 - Weight =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: -History of current PCOS or endometriosis stage III / IV -History of severe ovarian hyperstimulation syndrome; - Presence of hydrosalpinx by ultrasound; - History of recurrent consecutive miscarriages (> 3) -FSH> 12 IU / L (in the early follicular phase); - Contraindications for use of gonadotropins or GnRH analogues; -History of current epilepsy, HIV infection, diabetes or cardiovascular, gastrointestinal, hepatic, renal, or pulmonary disease; - Pregnancy, lactation or contraindication to pregnancy; - Current or previous (last 12 months) abuse of alcohol or drugs; - History of chemotherapy (except gestationelle reasons) and radiotherapy; - Undiagnosed vaginal bleeding; - Tumors of the ovary, breast, adrenal, pituitary or hypothalamus and malformations of sexual organs incompatible with pregnancy; - Abnormal karyotype of the patient (if karyotype is performed); - Hypersensitivity to study drug.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To show that the group randomized to individual AMH based stimulation achieves a more homogeneous distribution of the retrieved eggs than the group receiving standard treatment. Primary endpoint: The primary endpoint is an appropriate or an inappropriate number of oocytes: This should be understood in the term of patients in the two arms are classified as having an appropriate response (5 - 14 eggs) or inappropriate response ( 14 eggs); An inappropriate response includes those patients where the treatment is canceled due to either too few follicles or egg maturation with hCG omitted due to risk of OHSS (given as GnRH agonist (Suprefact) instead of);Secondary Objective: Not applicable;Primary end point(s): Primary endpoint The primary endpoint is an appropriate or an inappropriate number of oocytes: This should be understood so that the patients in the two arms are classified as having an appropriate response (5 - 14 eggs) or inappropriate response ( 14 eggs); An inappropriate response includes those patients where the treatment is canceled due to either too few follicles or egg maturation with hCG omitted due to risk of OHSS (given as GnRH agonist (Suprefact) instead of);Timepoint(s) of evaluation of this end point: Timepoint of endpoint for the primary endpoint is Marts 2016 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): -fertilization rate -Number transferede embryos - Number of patients who achieve blastocyst transfer ring - implantation rate - Duration of stimulation - Luteal phase inconvenience and enlargemen of ovaries - Clinical pregnancy (GA weeks 7-8);Timepoint(s) of evaluation of this end point: Timpoint will be Dec 2016 due to pregnancy at last patient | — |
Countries
Denmark
Contacts
Public ContactProfessor Anders Nyboe Andersen
Fertility Clinic, Copenhagen University Hospital, Rigshospitalet
Outcome results
None listed