The AID study: protocol for a randomised controlled trial of intrauterine insemination in the natural cycle compared with intracervical insemination in the natural cycle
Introduction At present, studies comparing intrauterine insemination in the natural cycle versus intracervical insemination in the natural cycle in women undergoing artificial insemination with donor sperm are scarce.Methods and analysis We perform a randomised controlled non-inferiority trial among...
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BMJ Publishing Group
2019-07-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/9/7/e026065.full |
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| author | Sjoerd Repping Ben Willem Mol Petronella Kop Rob Bernardus Michael De Brucker Pim Janssens Ben Cohlen Jacqueline Pieters Fulco van der Veen Monique H Mochtar |
| author_facet | Sjoerd Repping Ben Willem Mol Petronella Kop Rob Bernardus Michael De Brucker Pim Janssens Ben Cohlen Jacqueline Pieters Fulco van der Veen Monique H Mochtar |
| author_sort | Sjoerd Repping |
| collection | DOAJ |
| description | Introduction At present, studies comparing intrauterine insemination in the natural cycle versus intracervical insemination in the natural cycle in women undergoing artificial insemination with donor sperm are scarce.Methods and analysis We perform a randomised controlled non-inferiority trial among five secondary and tertiary fertility clinics in the Netherlands and one tertiary fertility clinic in Belgium. Women eligible for artificial insemination with donor sperm are included. We perform six cycles of artificial insemination with donor sperm within a time horizon of 8 months comparing intrauterine insemination in the natural cycle with intracervical insemination in the natural cycle. The primary outcome is ongoing pregnancy leading to live birth conceived within eight months after randomisation. Secondary outcomes are clinical pregnancy rate, miscarriage rate, multiple pregnancy rate, pregnancy complications (preterm birth, birth weight <2500 g, pregnancy induced hypertension, (pre-) eclampsia, Hemolysis Elevated Liver enzymes Low Platelets (HELLP)), time to ongoing pregnancy, direct and indirect costs. To demonstrate the non-inferiority of intracervical insemination with a margin of 12%, we need 208 women per arm.Ethics and dissemination The study has been approved by the Medical Ethical Committee of the Academic Medical Centre and from the Dutch Central Committee on research involving human subjects (47330-018-13). The boards of the participating hospitals approved the study. Results will be disseminated through peer-reviewed publications and presentations at international scientific meetings.Trial registration number NTR4462 |
| format | Article |
| id | doaj-art-4d2ecc68fbd342b393b64785490359e6 |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2019-07-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-4d2ecc68fbd342b393b64785490359e62024-11-29T00:10:07ZengBMJ Publishing GroupBMJ Open2044-60552019-07-019710.1136/bmjopen-2018-026065The AID study: protocol for a randomised controlled trial of intrauterine insemination in the natural cycle compared with intracervical insemination in the natural cycleSjoerd Repping0Ben Willem Mol1Petronella Kop2Rob Bernardus3Michael De Brucker4Pim Janssens5Ben Cohlen6Jacqueline Pieters7Fulco van der Veen8Monique H Mochtar9Department of Health Evaluation and Appropriate Use, University of Amsterdam, Amsterdam, The Netherlands24 Robinson Institute, School of Paediatrics and Reproductive Health, The University of Adelaide, Adelaide, Australia1 Center for Reproductive Medicine, Amsterdam Reproduction & Development Institute, Amsterdam UMC, University of Amsterdam, Amsterdam, Netherlands4 Fertility clinic, Nij Barrahus, Wolvega, Netherlands5 Centre for Reproductive Medicine, Universitair Ziekenhuis Brussel, Brussel, Belgium6 Clinical Chemistry and Haematology, Hospital Rijnstate, Arnhem, Gelderland, Netherlands7 Obstetrics and Gynaecology, Isala Hospitals, Zwolle, Overijssel, Netherlands8 Fertility clinic, Vivaneo Medisch Centrum Kinderwens, Leiderdorp, Netherlandsprofessor in reproductive medicine1 Center for Reproductive Medicine, Amsterdam Reproduction & Development Institute, Amsterdam UMC, University of Amsterdam, Amsterdam, NetherlandsIntroduction At present, studies comparing intrauterine insemination in the natural cycle versus intracervical insemination in the natural cycle in women undergoing artificial insemination with donor sperm are scarce.Methods and analysis We perform a randomised controlled non-inferiority trial among five secondary and tertiary fertility clinics in the Netherlands and one tertiary fertility clinic in Belgium. Women eligible for artificial insemination with donor sperm are included. We perform six cycles of artificial insemination with donor sperm within a time horizon of 8 months comparing intrauterine insemination in the natural cycle with intracervical insemination in the natural cycle. The primary outcome is ongoing pregnancy leading to live birth conceived within eight months after randomisation. Secondary outcomes are clinical pregnancy rate, miscarriage rate, multiple pregnancy rate, pregnancy complications (preterm birth, birth weight <2500 g, pregnancy induced hypertension, (pre-) eclampsia, Hemolysis Elevated Liver enzymes Low Platelets (HELLP)), time to ongoing pregnancy, direct and indirect costs. To demonstrate the non-inferiority of intracervical insemination with a margin of 12%, we need 208 women per arm.Ethics and dissemination The study has been approved by the Medical Ethical Committee of the Academic Medical Centre and from the Dutch Central Committee on research involving human subjects (47330-018-13). The boards of the participating hospitals approved the study. Results will be disseminated through peer-reviewed publications and presentations at international scientific meetings.Trial registration number NTR4462https://bmjopen.bmj.com/content/9/7/e026065.full |
| spellingShingle | Sjoerd Repping Ben Willem Mol Petronella Kop Rob Bernardus Michael De Brucker Pim Janssens Ben Cohlen Jacqueline Pieters Fulco van der Veen Monique H Mochtar The AID study: protocol for a randomised controlled trial of intrauterine insemination in the natural cycle compared with intracervical insemination in the natural cycle BMJ Open |
| title | The AID study: protocol for a randomised controlled trial of intrauterine insemination in the natural cycle compared with intracervical insemination in the natural cycle |
| title_full | The AID study: protocol for a randomised controlled trial of intrauterine insemination in the natural cycle compared with intracervical insemination in the natural cycle |
| title_fullStr | The AID study: protocol for a randomised controlled trial of intrauterine insemination in the natural cycle compared with intracervical insemination in the natural cycle |
| title_full_unstemmed | The AID study: protocol for a randomised controlled trial of intrauterine insemination in the natural cycle compared with intracervical insemination in the natural cycle |
| title_short | The AID study: protocol for a randomised controlled trial of intrauterine insemination in the natural cycle compared with intracervical insemination in the natural cycle |
| title_sort | aid study protocol for a randomised controlled trial of intrauterine insemination in the natural cycle compared with intracervical insemination in the natural cycle |
| url | https://bmjopen.bmj.com/content/9/7/e026065.full |
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