Therapeutic Endometrial Biopsy

Infertility Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01963819
• Other study ID #: Miacol-2013-1H
• 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
• 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

Related Conditions & MeSH terms

• ART
• Endometrial Biopsy
• Endometrium
• Infertility

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.