ART, Endometrial Biopsy, Endometrium, Infertility
Conditions
Brief summary
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.
Detailed description
Randomized controlled prospective clinical study.
Interventions
OTHEREndometrial biopsy
The endometrial biopsy will be done in the luteal phase (cycle day 18-22) prior to the treatment cycle (antagonist)
Sponsors
University of Aarhus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of clinical pregnancy | Individual outcome will be evaluated within 8 weekes after embryo transfer. Overall outcome will be evaluated after 3 years. |
Secondary
| Measure | Time frame |
|---|---|
| Rate of biochemical pregnancy | Individual outcome will be evaluated within 8 weeks after embryo transfer. Overall outcome will be evaluated after 3 years. |
| Rate of implantation | Individual outcome will be evaluated within 8 weekes after embryo transfer. Overall outcome will be evaluated after 3 years. |
| Rate of live birth | Individual outcome will be evaluated within 9 months after embryo transfer. Overall outcome will be evaluated after 3 years. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Rate of pregnancy complications | Individual outcome will be evaluated within 9 months after embryo transfer. Overall outcome will be evaluated after 3 years. | Placenta abnormalities, pregnancy related hypetensive disorders, IUGR, GDM |
| Data on children and placenta at birth | Individual outcome will be evaluated within 9 months after embryo transfer. Overall outcome will be evaluated after 3 years. | Gestationel age, Preterm birth, LGA/SGA/NGA, Gender, Placenta abnormalities |
Countries
Denmark
Contacts
Primary ContactMia Steengaard Olesen, MD
Backup ContactAxel Forman, MD, DMsc
Outcome results
None listed