Ovarian stimulation with follicle stimulating hormone (r-FSH) for women with high early follicular FSH and intra-uterine insemination (IUI) indication

ISRCTN	ISRCTN14825568
DOI	https://doi.org/10.1186/ISRCTN14825568
Secondary identifying numbers	NTR547; 03/203

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

Dr C.B. Lambalk
Scientific

VU University Medical Center
Department of Reproductive Medicine
P.O. Box 7057
Amsterdam
1007 MB
Netherlands

Phone	+31 (0)20 4440043
Email	cb.lambalk@vumc.nl

Study design	Randomised open label active controlled parallel group trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title
Study objectives	Hormonal stimulation with r-FSH during IUI treatment will result in multifollicular growth in subfertile women with elevated early follicular FSH values.
Ethics approval(s)	Received from local medical ethics committee
Health condition(s) or problem(s) studied	Subfertility
Intervention	Couples will undergo a maximum of 6 IUI cycles. Group 1: Three unstimulated IUI cycles, followed by three stimulated IUI cycles with r-FSH (follitropine). R-FSH will be given starting from day 3 of the cycle until one or more follicles reach 18 mm diameter, followed by hCG administration 10,000 IU and insemination. Dose will be increased in the next cycle until multifollicular growth occurs. Group 2: Six stimulated IUI cycles. R-FSH will be given starting from day 3 of the cycle until one or more follicles reach 18 mm diameter, followed by hCG administration 10,000 IU and insemination. Dose will be increased in the next cycle until multifollicular growth occurs.
Intervention type	Other
Primary outcome measure	Multifollicular growth (on day of hCG administration, measured with ultrasound).
Secondary outcome measures	1. Pregnancy rate 2. FSH doses used 3. Cancellation rate 4. Side-effects of medication 5. Treatment load
Overall study start date	01/04/2004
Completion date	01/04/2008

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Female
Target number of participants	80
Key inclusion criteria	1. Women with elevated early follicular FSH (cycle day 2-4) 2. Women between 18 and 45 years 3. Regular menstrual cycle between 25 and 35 days 4. Indication for IUI treatment 5. Normal hysterosalpingography 6. Normal serum Ca-125 7. Semen analyses: >2 million progressive motile spermatozoa 8. Ovulatory cycle
Key exclusion criteria	1. Untreated other endocrinal pathology 2. Abnormal vaginal blood loss of unknown origin 3. Contra-indications for use of r-FSH or human choronic gonadotropin (hCG) 4. Contra-indications for pregnancy 5. Congenital uterus anomaly 6. Endometriosis more than stage II (revised ASRM score)
Date of first enrolment	01/04/2004
Date of final enrolment	01/04/2008

VU University Medical Center

Amsterdam
1007 MB
Netherlands

VU University Medical Centre (VUMC) (Netherlands)
Hospital/treatment centre

Department of Obstetrics and Gynaecology
Division of Reproductive Medicine
P.O. Box 7057
Amsterdam
1007 MB
Netherlands

"ROR"	https://ror.org/00q6h8f30

Research organisation

Gynaecological Research Foundation (Stichting Wetenschappelijk Onderzoek Gynaecologie [SWOG])

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan