No registrations found.
ID
Source
Brief title
Health condition
subfertiliteit
subfertility
Sponsors and support
Intervention
Outcome measures
Primary outcome
Ongoing 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 outcome
1. 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.
Background summary
A 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.
Study objective
To evaluate the effect of 15 minutes of immobilisation after IUI on pregnancy rate in couples with unexplained, cervical factor or male subfertility.
Study design
N/A
Intervention
15 minutes immobilisation after IUI or immediate mobilisation.
P.O. Box 7057
R. Schats
Amsterdam 1007 MB
The Netherlands
+31 (0)20 4443266
R.schats@vumc.nl
P.O. Box 7057
R. Schats
Amsterdam 1007 MB
The Netherlands
+31 (0)20 4443266
R.schats@vumc.nl
Inclusion criteria
1. 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 postcoïtum tests are found.
Exclusion criteria
1. 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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL2313 |
| NTR-old | NTR2418 |
| Other | METc VUmc : 2010/090 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |