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A randomised clinical trial assessing the additional value of ovarian hyperstimulation in intrauterine insemination for couples with an abnormal post-coital test.


- candidate number1372
- NTR NumberNTR204
- ISRCTNISRCTN90142795
- Date ISRCTN created8-feb-2006
- date ISRCTN requested18-okt-2005
- Date Registered NTR12-sep-2005
- Secondary IDs
- Public TitleA randomised clinical trial assessing the additional value of ovarian hyperstimulation in intrauterine insemination for couples with an abnormal post-coital test.
- Scientific TitleA randomised clinical trial assessing the additional value of ovarian hyperstimulation in intrauterine insemination for couples with an abnormal post-coital test.
- ACRONYMsubfertility, cervical factor, IUI, ovarian hyperstimulation
- hypothesisWe hypothesized that controlled ovarian hyperstimulation (COH) is of additional value to IUI in couples with a cervical factor and a poor prognosis, i.e. < 30% spontaneous pregnancy chance in the next year.
- Healt Condition(s) or Problem(s) studiedSubfertility
- Inclusion criteriaCouples were eligible if they had an abnormal PCT, either due to cervical hostility diagnosed by a well-timed, non-progressive PCT with normal semen parameters or due to a poor semen quality.
The spontaneous pregnancy chance in the next year, leaving the result of the PCT out of consideration, was < 30%.
- Exclusion criteriaAll other subfertile couples.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jun-2002
- planned closingdate1-jul-2005
- Target number of participants250
- InterventionsThese couples were randomly allocated to three cycles IUI with COH or three cycles IUI without COH.
Controlled ovarian hyperstimulation as well as ovulation detection- induction, semen preparation and insemination regimens were performed according to hospital-specific protocols.
- Primary outcomeThe primary endpoint was ongoing pregnancy within three cycles of IUI.
Ongoing pregnancy was defined as the presence of foetal cardiac activity at transvaginal sonography at a gestational age of at least 12 weeks.
- Secondary outcomeSecondary endpoints were total number of clinical pregnancies, miscarriages and multiple pregnancies.
- TimepointsN/A
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIES P. Steures
- CONTACT for SCIENTIFIC QUERIES P. Steures
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- PublicationsFertil Steril. 2007 Dec;88(6):1618-24. Epub 2007 Jun 11.


Partly presented in an oral presentation at the Conjoint Annual Meeting of the American Societty for Reproductive Medicine and the Canadian Fertility and Andrology Society, ASRM/CFAS 2005, Montreal, Quebec, Canada.
- Brief summaryObjective:
At present, there is only one non-randomised study that assesses the effectiveness of controlled ovarian hyperstimulation (COH) in intrauterine insemination (IUI) for subfertile couples with a cervical factor. We evaluated the contribution of COH in couples with an abnormal post-coital test (PCT) undergoing IUI.


Design:
Randomised clinical trial.


Materials and methods:
We performed a randomised clinical trial in 24 Fertility Centers in The Netherlands. Couples were eligible if they had an abnormal PCT, either due to cervical hostility diagnosed by a well-timed, non-progressive PCT with normal semen parameters or due to a poor semen quality. These couples were randomly allocated to three cycles IUI with COH or three cycles IUI without COH.


The primary endpoint:
was ongoing pregnancy within three IUI cycles. The treatment effect was expressed as a relative risk and 95% confidence interval (CI). The analysis was performed according the intention to treat principle. In a subgroup-analysis, we evaluated the follicular growth patterns in relation to the occurrence of pregnancy. We assumed an equal effect in both groups with an ongoing pregnancy rate of 18% after 3 cycles. To show this equivalence with a maximum difference of 12%, an alpha of 5% and a power of 80%, 117 couples were required in each group.


Results:
At present, 250 couples have been included, and follow up for three cycles is available for 205 couples. In the IUI without COH group, 20 couples (19%) became pregnant of which 18 had an ongoing pregnancy (17%). In the IUI with COH group, 25 couples (26%) became pregnant, of which 23 had an ongoing pregnancy (24%). The relative risk of an ongoing pregnancy was 1.4 (95% CI 1.0 to 1.9). Two multiple pregnancies occurred in the IUI with COH group (8.7% of the ongoing pregnancies).
The fraction of IUI cycles with multifollicular growth was 43% in IUI with COH versus 3% in IUI without COH. Pregnancy rates with or without multifollicular growth were 9.5% and 11% per cycle, respectively, with ongoing pregnancy rates of 6.8% and 10% per cycle.


Conclusion:
This trial suggests that COH has an additional effect to IUI in couples with an abnormal PCT.
- Main changes (audit trail)
- RECORD5-sep-2005 - 28-aug-2008


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