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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.
Randomized controlled prospective clinical study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | Standard treatment | |
| Intervention | Experimental | Endometrial biopsy before standard treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endometrial biopsy | Other | The endometrial biopsy will be done in the luteal phase (cycle day 18-22) prior to the treatment cycle (antagonist) |
|
| Measure | Description | 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. |
| Measure | Description | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Data on children and placenta at birth |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mia Steengaard Olesen, MD | Contact | +4578426562 | miaolsen@rm.dk | |
| Axel Forman, MD, DMsc | Contact | axel.forman@ki.au.dk |
| Name | Affiliation | Role |
|---|---|---|
| Axel Forman, MD, DMsc | Departement of Gynaecology and Obstetrics, Aarhus University Hospital, Skejby | Study Director |
| Inge E Agerholm, M.Sc, PhD | Fertility Clinic, Horsens Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fertility Clinic, Dronninglund Hospital (Aalborg University Hospital) | Recruiting | Dronninglund | Denmark | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31843072 | Derived | 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. |
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| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| Rate of live 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 |
| Individual outcome will be evaluated within 9 months after embryo transfer. Overall outcome will be evaluated after 3 years. |
| Benedicte Hauge, MD | Fertility Clinic, Horsens Hospital | Principal Investigator |
| Peter Humaidan, MD, DMSc | Fertility Clinic, Skive Hospital | Principal Investigator |
| Mia Steengaard Olesen, MD | Fertility Clinic Horsens Hospital, Aarhus University | Principal Investigator |
| Fertility Clinic, Horsens Hospital |
| Recruiting |
| Horsens |
| Denmark |
|
| Fertility Clinic, Skive Hospital | Recruiting | Skive | Denmark |