Condition category
Urological and Genital Diseases
Date applied
09/01/2006
Date assigned
09/01/2006
Last edited
25/08/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

Sponsor information

Organisation

Isala Clinics, Sophia (Isala Klinieken Locatie Sophia) (Netherlands)

Sponsor details

P.O. Box 10400
Zwolle
8000 GK
Netherlands

Sponsor type

Hospital/treatment centre

Website

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

Publication citations

Additional files

Editorial Notes