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Immobilisation or direct mobilisation after intrauterine insemination effects pregnancy rates? A randomised controlled trial.


- candidate number8247
- NTR NumberNTR2418
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR20-jul-2010
- Secondary IDs2010/090 METc VUmc
- Public TitleImmobilisation or direct mobilisation after intrauterine insemination effects pregnancy rates? A randomised controlled trial.
- Scientific TitleImmobilisation or direct mobilisation after intrauterine insemination effects pregnancy rates? A randomised controlled trial.
- ACRONYMIUI up or down
- hypothesisTo evaluate the effect of 15 minutes of immobilisation after IUI on pregnancy rate in couples with unexplained, cervical factor or male subfertility.
- Healt Condition(s) or Problem(s) studiedSubfertility
- Inclusion criteria1. All couples with unexplained, cervical factor or male subfertility, with an indication for IUI;
2. All couples should have undergone an infertility work up including at least an hysterosalpingogram (HSG);
3. Unexplained subfertility will be diagnosed when ovulation is confirmed with a biphasic BTC and / or midluteal progesterone determination and HSG and / or laparoscopy have confirmed tubal patency at both sides;
4. In case of male factor the male partners should have semen analyses with a yield of > 2 million spermatozoa, but less than 10 million spermatozoa, after processing;
5. Subfertility due to cervical factor will be diagnosed when negative, well-timed postco´tum tests are found.
- Exclusion criteria1. Cycles with a yield of < 2 x 106 spermatozoa at time of insemination will be excluded from analysis;
2. Patients needing insemination with cryo-preserved semen or semen retrieved after flushing of the bladder will be excluded;
3. Patients with endocrine disorders like polycystic ovary syndrome or imminent ovarian failure (basal FSH > 12 IU IU/L) will be excluded as well.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jun-2010
- planned closingdate1-aug-2012
- Target number of participants500
- Interventions15 minutes immobilisation after IUI or immediate mobilisation.
- Primary outcomeOngoing pregnancy rate per couple. Ongoing pregnancy is defined as an intrauterine pregnancy showing a normal developing foetus with positive heartbeat 10 weeks following IUI.
- Secondary outcome1. Ongoing pregnancy rate per cycle;
2. Pregnancy rate per couple and per cycle;
3. Cumulative pregnancy rate per couple;
4. Multiple gestation rate per ongoing pregnancy;
5. Miscarriage rate per couple.
- TimepointsN/A
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDr. R. Schats
- CONTACT for SCIENTIFIC QUERIESDr. R. Schats
- Sponsor/Initiator VU University Medical Center, Department of Obstetrics and Gynaecology
- Funding
(Source(s) of Monetary or Material Support)
- PublicationsN/A
- Brief summaryA single centre prospective randomized controlled trial to evaluate the effect of 15 minutes of immobilisation on IUI on the pregnancy rate in couples with unexplained, cervical factor or male subfertility at the VU University Medical Center, The Netherlands.
- Main changes (audit trail)
- RECORD20-jul-2010 - 5-aug-2010


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