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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01963819
Other study ID # Miacol-2013-1H
Secondary ID
Status Recruiting
Phase N/A
First received October 11, 2013
Last updated March 15, 2018
Start date January 2014
Est. completion date December 2018

Study information

Verified date March 2018
Source University of Aarhus
Contact Mia Steengaard Olesen, MD
Phone +4578426562
Email miaolsen@rm.dk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

Randomized controlled prospective clinical study.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Endometrial biopsy
The endometrial biopsy will be done in the luteal phase (cycle day 18-22) prior to the treatment cycle (antagonist)

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

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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