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
Protocol serial number	NTR547; 03/203
Sponsor	VU University Medical Centre (VUMC) (Netherlands)
Funder	Gynaecological Research Foundation (Stichting Wetenschappelijk Onderzoek Gynaecologie [SWOG])

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

Primary study design	Interventional
Study design	Randomised open label active controlled parallel group trial
Secondary study design	Randomised controlled trial
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(s)	Multifollicular growth (on day of hCG administration, measured with ultrasound).
Key secondary outcome measure(s)	1. Pregnancy rate 2. FSH doses used 3. Cancellation rate 4. Side-effects of medication 5. Treatment load
Completion date	01/04/2008

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Female
Target sample size at registration	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

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