Contact information
Type
Scientific
Primary contact
Dr B.J. Cohlen
ORCID ID
Contact details
Isala Clinics Zwolle
location Sophia
Department of Reproductive Medicine
Division of Obstetrics and Gynaecology
P.O. Box 10400
Zwolle
8000 GK
Netherlands
+31 (0)38 4245000
b.j.cohlen@isala.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NTR497
Study information
Scientific title
Acronym
IUI study IMP 26162
Study hypothesis
We 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.
Ethics approval
Received from local medical ethics committee
Study design
Multicentre randomised double blind placebo controlled parallel group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Intrauterine Insemination (IUI), Infertility, Subfertility
Intervention
The research group of patients will consist of two arms:
One group will receive ovarian stimulation with recFSH combined with placebo (the recFSH group).
One group will receive recFSH combined with a GnRH-antagonist (the recFSH-anta group).
Both ovarian stimulation protocols will be followed by intrauterine insemination.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Live birth rate per couple
Secondary outcome measures
1. 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.)
Overall trial start date
15/11/2005
Overall trial end date
14/11/2007
Reason abandoned
Eligibility
Participant inclusion criteria
Primary and secondary subfertile patients between 18 and 35 years of age with a diagnosis of unexplained or mild male infertility will be included.
Definition of unexplained subfertility:
1. Normozoospermia using the guidelines of the WHO
2. Patent Fallopian tubes (both ovaries should be in situ)
3. Cycles varying between 24 and 35 days with an indication of ovulation
4. 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.
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
520
Participant exclusion criteria
1. Age of the woman <18 or >35 years
2. Duration of subfertility below 2 years
3. Manifest pathology of the Fallopian tubes
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
Recruitment start date
15/11/2005
Recruitment end date
14/11/2007
Locations
Countries of recruitment
Netherlands
Trial participating centre
Isala Clinics Zwolle, location Sophia
Zwolle
8000 GK
Netherlands
Funders
Funder type
Research council
Funder name
Reproductive Medicine Research and Education Foundation (Stichting Onderzoek en Onderwijs Voortplantingsgeneeskunde Zwolle [SOOVZ]) (Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Serono Benelux B.V. (Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary