Infertility Clinical Trial
The aim of this study is to evaluate the potential benefits in implantation, clinical
pregnancy and live birth rates by an endometrial biopsy prior to an IVF/ICSI treatment.
Including a follow up on possible pregnancy complications and data on children at birth.
Further it is planned to aspirate secretions from the uterus and take blood samples during
the treatment, which presumably can provide information about the mechanisms underlying the
possible effect of the treatment.
Status | Recruiting |
Enrollment | 300 |
Est. completion date | December 2018 |
Est. primary completion date | December 2018 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 40 Years |
Eligibility |
Inclusion Criteria: - One or more previous failed implantation despite transfer of good quality embryons/blastocyst in a fresh IVF/ICSI treatment - Planned Antagonist treatment - Planned Standardized hormone treatment - FSH: 2-12 IU/L - Age: 18-40 years - BMI: 18-32 - Regular menstrual cycles - Written consent Exclusion Criteria: - Patients in need for a interpreter - Suspected intrauterine abnormalities ( fibromes, polyps, adenomyosis, sactosalpinges) - Planned use og Assisted hatching or use of specialized media - Previous inclusion in the study |
Country | Name | City | State |
---|---|---|---|
Denmark | Fertility Clinic, Dronninglund Hospital (Aalborg University Hospital) | Dronninglund | |
Denmark | Fertility Clinic, Horsens Hospital | Horsens | |
Denmark | Fertility Clinic, Skive Hospital | Skive |
Lead Sponsor | Collaborator |
---|---|
University of Aarhus |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Rate of pregnancy complications | Placenta abnormalities, pregnancy related hypetensive disorders, IUGR, GDM | Individual outcome will be evaluated within 9 months after embryo transfer. Overall outcome will be evaluated after 3 years. | |
Other | Data on children and placenta at birth | Gestationel age, Preterm birth, LGA/SGA/NGA, Gender, Placenta abnormalities | Individual outcome will be evaluated within 9 months after embryo transfer. Overall outcome will be evaluated after 3 years. | |
Primary | Rate of clinical pregnancy | Individual outcome will be evaluated within 8 weekes after embryo transfer. Overall outcome will be evaluated after 3 years. | ||
Secondary | Rate of biochemical pregnancy | Individual outcome will be evaluated within 8 weeks after embryo transfer. Overall outcome will be evaluated after 3 years. | ||
Secondary | Rate of implantation | Individual outcome will be evaluated within 8 weekes after embryo transfer. Overall outcome will be evaluated after 3 years. | ||
Secondary | Rate of live birth | Individual outcome will be evaluated within 9 months after embryo transfer. Overall outcome will be evaluated after 3 years. |
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