An AMH based indivdualised controlled ovarian stimulation regiment usingCorifollitrophin Alphs or graded doses of rFSH versus a standard protocol.A randomised controlled trial

Phase 1

Conditions: In vitro fertilization include controlled ovarian stimulation (COS), wherefollicles are stimulated to full maturity.One of the main problems of the IVF treatment is still to some patientsdevelop a very large number of follicles, and others only a few. A largenumber of follicles (eggs) increases the risk of ovarian hyperstimulationsyndrome (OHSS), while few follicles (eggs) reduces the chance ofpregnancy.
MedDRA version: 14.1Level: LLTClassification code 10021930Term: Infertility NOSSystem Organ Class: 100000004872
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]

Registration Number: EUCTR2012-004969-40-DK

Lead Sponsor: Fertility Clinic, Copenhagen University Hospital, Rigshospitalet

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Female

Target Recruitment: Not specified

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 <75kg
- Normal menstrual cycle length of 24 to 35 days, which are presumably
ovulatory;
- Two ovaries;
- Uterus with expected normal function (eg. No clinically significant
fribromer) documented by ultrasound at screening;
- Willing and able to sign the informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 216
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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.