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van CCT (UK)

van CCT (UK)

The efficacy of GnRH antagonists in cycles with mild ovarian hyperstimulation with recFSH in an intrauterine insemination program.
A randomised placebo-controlled double-blinded investigator initiated study.

- candidate number1813
- NTR NumberNTR497
- Date ISRCTN created9-jan-2006
- date ISRCTN requested13-dec-2005
- Date Registered NTR6-nov-2005
- Secondary IDsN/A 
- Public TitleThe efficacy of GnRH antagonists in cycles with mild ovarian hyperstimulation with recFSH in an intrauterine insemination program.
A randomised placebo-controlled double-blinded investigator initiated study.
- Scientific TitleThe efficacy of GnRH antagonists in cycles with mild ovarian hyperstimulation with recFSH in an intrauterine insemination program.
A randomised placebo-controlled double-blinded investigator initiated study.
- ACRONYMIUI study IMP 26162
- hypothesisWe hypothesize that the use of a GnRH-antagonist in cycles with Mild Ovarian Hyperstimulation (MOH) combined with Intrauterine insemination (IUI) programs significantly improves live birth rates compared with MOH and a placebo.
- Healt Condition(s) or Problem(s) studiedSubfertility, Infertility, Intra-uterine insemination (IUI)
- Inclusion criteriaPrimary and secondary subfertile patients between 18 and 35 years of age with a diagnosis of unexplained or mild male infertility (see above) will be included.
Definition of unexplained subfertility:
normozoospermia using the guidelines of the WHO;
patent Fallopian tubes (both ovaries should be in situ);
cycles varying between 24 and 35 days with an indication of ovulation;
no abnormalities at laparoscopy and/or hysterosalpingography.
Information from the post-coital test when performed will only be used for a prognostic model and not as an exclusion criterion.
- Exclusion criteria1. Age of the woman < 18 or > 35 years;
2. Duration of subfertility below 2 years;
3. Manifest pathology of the Fallopiantubes;
4. Severe forms of endometriosis (when laparoscopy has been performed: > AFS II);
5. An average total number of motile spermatozoa during semen analysis (performed twice in case of abnormal findings) below 10 million;
6. Cycle disturbances (where otherwise ovulation induction would be used);
7. Previous IUI or IVF/ICSI treatment;
8. If an initial ultrasound shows an image of a cyst that is larger than 25 mm treatment will be postponed for 1 month. Persistence of a cyst is a reason for exclusion;
9. Contraindications for recFSH (Gonal-F), rec-hCG (Ovitrelle) and Cetrotide.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 15-nov-2005
- planned closingdate1-feb-2009
- Target number of participants520
- InterventionsThe research group of patients will consist of two arms:
one group will receive ovarian stimulation with recFSH combined with placebo (the recFSH group)
and one group will receive recFSH combined with a GnRH-antagonist (the recFSH-anta group).
Both ovarian stimulation protocols will be followed by intrauterine insemination.
- Primary outcomeLive birth rate per couple.
- Secondary outcome1. Total costs and cost-effectiveness;
2. Ongoing (> 12 weeks amenorrhoea) pregnancy rate per cycle commenced;
3. Miscarriages (Preclinical miscarriage: spontaneous cessation of a biochemical pregnancy.
Early miscarriage:
any spontaneous abortion occurring after confirmation of clinical pregnancy and before completed 12 weeks of gestation.
Late miscarriage:
any spontaneous abortion occurring between completed 12 weeks of gestation and 16 completed weeks of gestation) and ectopic pregnancies;
4. Cumulative ongoing pregnancy rates per couple;
5. Multiple births including the chorionicity;
6. The occurrence of an LH surge or premature luteinization;
7. Response of the ovaries to stimulation (number of follicles on day of Ovitrelle administration, speed of development, length of stimulation, quantities of medication used, etc.).
- Timepoints
- Trial web siteN/A
- statusplanned
- Sponsor/Initiator Isala klinieken, Locatie Sophia
- Funding
(Source(s) of Monetary or Material Support)
Serono Benelux B.V., Stichting Onderzoek en Onderwijs Voortplantingsgeneeskunde Zwolle (SOOVZ)
- PublicationsN/A
- Brief summaryAccurate timing of insemination is one of the most important variables that affect the result of intrauterine insemination (IUI).
The onset of the preovulatory luteinizing hormone (LH) surge is one of the best indicators of the initiation of ovulation.
The LH rise can be detected in blood. In cycles with ovarian stimulation spontaneous LH surges occur in 25% of the cases, hardly resulting in any pregnancy and are therefore useless.
Luteinizing hormone surges can be prevented by administering a GnRH-antagonist. When used from a mean diameter of 14 mm of the dominant follicle(s) onwards, it has to be applied for a few days.
Preventing LH surges with administering an effective drug might be cost-effective.
It seems therefore logical to perform a large multicentre randomised controlled trial to investigate the efficacy of applying a GnRH-antagonist in MOH/IUI programs.
The results of a multi-centre trial were presented at the ESHRE 2004, showing effective suppression of LH surges by the antagonist, but no significant differences in pregnancy rates.
The authors stated that larger multi-centre double-blinded placebo-controlled trials are mandatory.
The aim of the study is to examine the efficacy of GnRH-antagonists in cycles with ovarian stimulation with recombinant Follicle Stimulating Hormone (FSH) combined with IUI.
This will be done in a prospectively randomised placebo controlled trial in couples with unexplained and mild male subfertility for at least 2 years.
Use will be made of recombinant FSH (Gonal-F, Serono Benelux). 75 IU Gonal-F will be administered daily subcutaneously. Gonal-F stimulation will start on cycle day 2 to 4.
From a follicle size of at least 14 mm onwards Cetrorelix (Cetrotide, Serono Benelux) 0.25 mg will be administered subcutaneously or an equal volume equivalent of placebo.
Rec-hCG (250 μg Ovitrelle, Serono Benelux) will be administered on the day that the size of the largest follicle is at least 18 mm. Once-only insemination will take place 38-40 hours after administration of Ovitrelle.
Live birth rates will be treated as primary end points. Pregnancy rates per couple, the occurrence of spontaneous LH surges and premature luteinization, multiple pregnancy rates, miscarriage rates and rates of ectopic pregnancies, total costs and cost-effectiveness will be secondary end-points.
Because this study will be the same as the standard treatment the patients will not be exposed to additional risks. Except the injection of cetrorelix for a couple of days and the withdrawal of blood on the day of hCG no extra events will take place compared to the standard treatment.
- Main changes (audit trail)
- RECORD6-nov-2005 - 1-jul-2008

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