Clinical trial NCT01963819: Therapeutic Endometrial Biopsy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Infertility
Endometrium
ART
Endometrial Biopsy
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2013-10-16
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Rate of clinical pregnancy
timeFrame: Individual outcome will be evaluated within 8 weekes after embryo transfer. Overall outcome will be evaluated after 3 years.
Secondary outcomes:
measure: Rate of biochemical pregnancy
timeFrame: Individual outcome will be evaluated within 8 weeks after embryo transfer. Overall outcome will be evaluated after 3 years.
measure: Rate of implantation
timeFrame: Individual outcome will be evaluated within 8 weekes after embryo transfer. Overall outcome will be evaluated after 3 years.
measure: Rate of live birth
timeFrame: Individual outcome will be evaluated within 9 months after embryo transfer. Overall outcome will be evaluated after 3 years.
Other outcomes:
measure: Rate of pregnancy complications
timeFrame: Individual outcome will be evaluated within 9 months after embryo transfer. Overall outcome will be evaluated after 3 years.
measure: Data on children and placenta at birth
timeFrame: Individual outcome will be evaluated within 9 months after embryo transfer. Overall outcome will be evaluated after 3 years.
Locations:
city: Dronninglund
country: Denmark
facility: Fertility Clinic, Dronninglund Hospital (Aalborg University Hospital)
city: Horsens
country: Denmark
facility: Fertility Clinic, Horsens Hospital
city: Skive
country: Denmark
facility: Fertility Clinic, Skive Hospital
Study officials:
affiliation: Departement of Gynaecology and Obstetrics, Aarhus University Hospital, Skejby
name: Axel Forman, MD, DMsc
role: STUDY_DIRECTOR
affiliation: Fertility Clinic, Horsens Hospital
name: Inge E Agerholm, M.Sc, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Fertility Clinic, Horsens Hospital
name: Benedicte Hauge, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Fertility Clinic, Skive Hospital
name: Peter Humaidan, MD, DMSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Fertility Clinic Horsens Hospital, Aarhus University
name: Mia Steengaard Olesen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Olesen MS, Hauge B, Ohrt L, Olesen TN, Roskaer J, Baek V, Elbaek HO, Nohr B, Nyegaard M, Overgaard MT, Humaidan P, Forman A, Agerholm I. Therapeutic endometrial scratching and implantation after in vitro fertilization: a multicenter randomized controlled trial. Fertil Steril. 2019 Dec;112(6):1015-1021. doi: 10.1016/j.fertnstert.2019.08.010.