Infertility Clinical Trial
— AMHOfficial title:
Predictive Value of AMH (AMH=Anti Müllerian Hormone ) in IVF (IVF=In Vitro Fertilization ); a Prospective Randomized Controlled Trial
The primary aim of this trial is to compare two groups of women undergoing IVF (IVF=in vitro fertilisation ) treatment, to investigate if assessment of AMH (AMH=Anti-Müllerian hormone ), in addition to assessment of maternal age, AFC (AFC=antral follicle count ) and BMI (BMI=body mass index ) gives a more optimal COH (COH=controlled ovarian stimulation than does assessment of only age, AFC and BMI, measured as number of patients obtaining 5-12 oocytes during COH.
Status | Completed |
Enrollment | 308 |
Est. completion date | September 2016 |
Est. primary completion date | May 2016 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 40 Years |
Eligibility |
Inclusion Criteria: 1. Indication for IVF with standard method for the couple exists (i.e. more than one year of infertility and work-up has been performed suggesting IVF as the proper treatment and no known severe male factor exists). 2. Age >18 and < 40 years. 3. BMI > 18 and < 35. 4. First IVF treatment for the woman. 5. Willing to participate in randomization between intervention group and control group and to sign informed consent. Exclusion Criteria: 1. IVF with ICSI (ICSI=intracytoplasmic sperm injection ) planned. 2. Oocyte donation planned. 3. Treatment with PGD (PGD=preimplantation genetic diagnosis ) planned. 4. Medical or psychological condition indicating ineligibility for the study. 5. Patient with insufficient knowledge of Swedish language to understand patient information. 6. Previous participation in this study. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Sweden | Sahlgrenska University Hospital, Reproductive medicine, | Gothenburg |
Lead Sponsor | Collaborator |
---|---|
Ann Thurin Kjellberg |
Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of patients obtaining 5-12 oocytes during COH | 2 years | No | |
Secondary | Cancelled cycle rate | 2 years | No | |
Secondary | Total dose of gonadotropins | 2 years | No | |
Secondary | Number of participants developing moderate or severe OHSS | Follow-up of OHSS rate performed 4 weeks after ovum pick up | 2 years | No |
Secondary | Embryology | Number of oocytes retrieved, fertilization rate, number of good quality embryos, number of surplus embryos possible to cryopreserve, number of embryos transferred | 2 years | No |
Secondary | Pregnancy and live birth rate | 2 years | No |
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