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.

ISRCTN	ISRCTN15295216
DOI	https://doi.org/10.1186/ISRCTN15295216
Protocol serial number	NTR497
Sponsor	Isala Clinics, Sophia (Isala Klinieken Locatie Sophia) (Netherlands)
Funders	Reproductive Medicine Research and Education Foundation (Stichting Onderzoek en Onderwijs Voortplantingsgeneeskunde Zwolle [SOOVZ]) (Netherlands), Serono Benelux B.V. (Netherlands)

Submission date: 09/01/2006
Registration date: 09/01/2006
Last edited: 25/08/2009

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Urological and Genital Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr B.J. Cohlen
Scientific

Isala Clinics Zwolle, location Sophia
Department of Reproductive Medicine
Division of Obstetrics and Gynaecology
P.O. Box 10400
Zwolle
8000 GK
Netherlands

Phone	+31 (0)38 4245000
Email	b.j.cohlen@isala.nl

Study information

Primary study design	Interventional
Study design	Multicentre randomised double blind placebo controlled parallel group trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	IUI study IMP 26162
Study objectives	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(s)	Received from local medical ethics committee
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	Live birth rate per couple
Key secondary outcome measure(s)	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.)
Completion date	14/11/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	35 Years
Sex	Female
Target sample size at registration	520
Key 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.
Key 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
Date of first enrolment	15/11/2005
Date of final enrolment	14/11/2007

Locations

Countries of recruitment

Netherlands

Study participating centre

Isala Clinics Zwolle, location Sophia

Zwolle
8000 GK
Netherlands

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan