Individual versus standard dose of rFSH in a mild stimulation protocol for intrauterine insemination: a randomized study

N la Cour Freiesleben; K Lossl; J Bogstad; H E Bredkjaer; B Toft; M Rosendahl; A Loft; S Bangsboll; A Pinborg; A Nyboe Andersen; N la Cour Freiesleben; Kristine Løssl; J Bogstad; H E Bredkjaer; Bente Toft; M Rosendahl; A Loft; Susanne Bangsbøll-Andersen; A Pinborg; Anders Nyboe Andersen

doi:10.1093/humrep/dep239

Individual versus standard dose of rFSH in a mild stimulation protocol for intrauterine insemination: a randomized study

N la Cour Freiesleben, K Lossl, J Bogstad, H E Bredkjaer, B Toft, M Rosendahl, A Loft, S Bangsboll, A Pinborg, A Nyboe Andersen, N la Cour Freiesleben, Kristine Løssl, J Bogstad, H E Bredkjaer, Bente Toft, M Rosendahl, A Loft, Susanne Bangsbøll-Andersen, A Pinborg, Anders Nyboe Andersen

9 Citations (Scopus)

Abstract

BACKGROUND: Controlled ovarian stimulation (COS) and intrauterine insemination (IUI) are often used as the first-line treatment for subfertile couples. To minimize the variability in ovarian response in patients' first treatment cycle, we recently developed a recombinant follicle-stimulating hormone (rFSH) dosage nomogram. The nomogram has now been tested. METHODS: Multicentre randomized controlled trial (RCT) including 228 ovulatory patients scheduled for COS and IUI. Patients were randomized to 'individual' (50-100 IU rFSH/day, n = 113) or 'standard' (75 IU rFSH/day, n = 115) dose. 'Individual' dose was prescribed according to the nomogram, which was based on patients' body weight and antral follicle count. The primary end-point was the proportion of patients with two to three follicles > or = 14 mm (maximum two follicles > or = 18 mm) on the day of hCG (leading follicle = 18 mm). Primary analysis was made by intention-to-treat. RESULTS: In the 'individual' group, 79/113 (70%) of the patients developed two to three follicles versus 64/115 (56%) in the 'standard' group [absolute difference = 14.3 percentage points; 95% confidence interval (CI) 2-26, P = 0.03; absolute difference = 14.4; 95% CI 2-27, P = 0.02, when adjusting for centre]. Among patients with two to three follicles, the proportion of patients with two follicles was 46/79 (58%) in the 'individual' group versus 34/64 (53%) in the 'standard' group, P = 0.54. Ongoing pregnancy rate was 23/113 (20%) in the 'individual' group and 21/115 (18%) in the 'standard' group and the rate of multiple gestations was 1/113 (1%) versus 5/115 (4%), P = 0.21. CONCLUSIONS: This RCT is the first to clinically test a dosage nomogram in ovulatory IUI patients' first rFSH treatment cycle. Dosing according to the nomogram was superior to standard dosing. Trial registration: ClinicalTrials.gov Identifier NCT00374634.

Original language	English
Journal	Human Reproduction
Volume	24
Issue number	10
Pages (from-to)	2523-30
Number of pages	8
ISSN	0268-1161
DOIs	https://doi.org/10.1093/humrep/dep239 https://doi.org/10.1093/humrep/dep239
Publication status	Published - 1 Oct 2009

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la Cour Freiesleben, N., Lossl, K., Bogstad, J., Bredkjaer, H. E., Toft, B., Rosendahl, M., Loft, A., Bangsboll, S., Pinborg, A., Nyboe Andersen, A., la Cour Freiesleben, N., Løssl, K., Bogstad, J., Bredkjaer, H. E., Toft, B., Rosendahl, M., Loft, A., Bangsbøll-Andersen, S., Pinborg, A., & Andersen, A. N. (2009). Individual versus standard dose of rFSH in a mild stimulation protocol for intrauterine insemination: a randomized study. Human Reproduction, 24(10), 2523-30. https://doi.org/10.1093/humrep/dep239, https://doi.org/10.1093/humrep/dep239

la Cour Freiesleben, N, Lossl, K, Bogstad, J, Bredkjaer, HE, Toft, B, Rosendahl, M, Loft, A, Bangsboll, S, Pinborg, A, Nyboe Andersen, A, la Cour Freiesleben, N, Løssl, K, Bogstad, J, Bredkjaer, HE, Toft, B, Rosendahl, M, Loft, A, Bangsbøll-Andersen, S, Pinborg, A & Andersen, AN 2009, 'Individual versus standard dose of rFSH in a mild stimulation protocol for intrauterine insemination: a randomized study', Human Reproduction, vol. 24, no. 10, pp. 2523-30. https://doi.org/10.1093/humrep/dep239, https://doi.org/10.1093/humrep/dep239

@article{f887b62067fb11df928f000ea68e967b,

title = "Individual versus standard dose of rFSH in a mild stimulation protocol for intrauterine insemination: a randomized study",

abstract = "BACKGROUND: Controlled ovarian stimulation (COS) and intrauterine insemination (IUI) are often used as the first-line treatment for subfertile couples. To minimize the variability in ovarian response in patients' first treatment cycle, we recently developed a recombinant follicle-stimulating hormone (rFSH) dosage nomogram. The nomogram has now been tested. METHODS: Multicentre randomized controlled trial (RCT) including 228 ovulatory patients scheduled for COS and IUI. Patients were randomized to 'individual' (50-100 IU rFSH/day, n = 113) or 'standard' (75 IU rFSH/day, n = 115) dose. 'Individual' dose was prescribed according to the nomogram, which was based on patients' body weight and antral follicle count. The primary end-point was the proportion of patients with two to three follicles > or = 14 mm (maximum two follicles > or = 18 mm) on the day of hCG (leading follicle = 18 mm). Primary analysis was made by intention-to-treat. RESULTS: In the 'individual' group, 79/113 (70%) of the patients developed two to three follicles versus 64/115 (56%) in the 'standard' group [absolute difference = 14.3 percentage points; 95% confidence interval (CI) 2-26, P = 0.03; absolute difference = 14.4; 95% CI 2-27, P = 0.02, when adjusting for centre]. Among patients with two to three follicles, the proportion of patients with two follicles was 46/79 (58%) in the 'individual' group versus 34/64 (53%) in the 'standard' group, P = 0.54. Ongoing pregnancy rate was 23/113 (20%) in the 'individual' group and 21/115 (18%) in the 'standard' group and the rate of multiple gestations was 1/113 (1%) versus 5/115 (4%), P = 0.21. CONCLUSIONS: This RCT is the first to clinically test a dosage nomogram in ovulatory IUI patients' first rFSH treatment cycle. Dosing according to the nomogram was superior to standard dosing. Trial registration: ClinicalTrials.gov Identifier NCT00374634.",

author = "{la Cour Freiesleben}, N and K Lossl and J Bogstad and Bredkjaer, {H E} and B Toft and M Rosendahl and A Loft and S Bangsboll and A Pinborg and {Nyboe Andersen}, A and {la Cour Freiesleben}, N and Kristine L{\o}ssl and J Bogstad and Bredkjaer, {H E} and Bente Toft and M Rosendahl and A Loft and Susanne Bangsb{\o}ll-Andersen and A Pinborg and Andersen, {Anders Nyboe}",

note = "Keywords: Adult; Body Weight; Female; Follicle Stimulating Hormone, Human; Hormones; Humans; Insemination, Artificial; Nomograms; Ovary; Ovulation Induction; Pregnancy; Pregnancy Rate; Recombinant Proteins",

year = "2009",

month = oct,

day = "1",

doi = "10.1093/humrep/dep239",

language = "English",

volume = "24",

pages = "2523--30",

journal = "Human Reproduction",

issn = "0268-1161",

publisher = "Oxford Academic",

number = "10",

}

TY - JOUR

T1 - Individual versus standard dose of rFSH in a mild stimulation protocol for intrauterine insemination: a randomized study

AU - la Cour Freiesleben, N

AU - Lossl, K

AU - Bogstad, J

AU - Bredkjaer, H E

AU - Toft, B

AU - Rosendahl, M

AU - Loft, A

AU - Bangsboll, S

AU - Pinborg, A

AU - Nyboe Andersen, A

AU - la Cour Freiesleben, N

AU - Løssl, Kristine

AU - Bogstad, J

AU - Bredkjaer, H E

AU - Toft, Bente

AU - Rosendahl, M

AU - Loft, A

AU - Bangsbøll-Andersen, Susanne

AU - Pinborg, A

AU - Andersen, Anders Nyboe

N1 - Keywords: Adult; Body Weight; Female; Follicle Stimulating Hormone, Human; Hormones; Humans; Insemination, Artificial; Nomograms; Ovary; Ovulation Induction; Pregnancy; Pregnancy Rate; Recombinant Proteins

PY - 2009/10/1

Y1 - 2009/10/1

N2 - BACKGROUND: Controlled ovarian stimulation (COS) and intrauterine insemination (IUI) are often used as the first-line treatment for subfertile couples. To minimize the variability in ovarian response in patients' first treatment cycle, we recently developed a recombinant follicle-stimulating hormone (rFSH) dosage nomogram. The nomogram has now been tested. METHODS: Multicentre randomized controlled trial (RCT) including 228 ovulatory patients scheduled for COS and IUI. Patients were randomized to 'individual' (50-100 IU rFSH/day, n = 113) or 'standard' (75 IU rFSH/day, n = 115) dose. 'Individual' dose was prescribed according to the nomogram, which was based on patients' body weight and antral follicle count. The primary end-point was the proportion of patients with two to three follicles > or = 14 mm (maximum two follicles > or = 18 mm) on the day of hCG (leading follicle = 18 mm). Primary analysis was made by intention-to-treat. RESULTS: In the 'individual' group, 79/113 (70%) of the patients developed two to three follicles versus 64/115 (56%) in the 'standard' group [absolute difference = 14.3 percentage points; 95% confidence interval (CI) 2-26, P = 0.03; absolute difference = 14.4; 95% CI 2-27, P = 0.02, when adjusting for centre]. Among patients with two to three follicles, the proportion of patients with two follicles was 46/79 (58%) in the 'individual' group versus 34/64 (53%) in the 'standard' group, P = 0.54. Ongoing pregnancy rate was 23/113 (20%) in the 'individual' group and 21/115 (18%) in the 'standard' group and the rate of multiple gestations was 1/113 (1%) versus 5/115 (4%), P = 0.21. CONCLUSIONS: This RCT is the first to clinically test a dosage nomogram in ovulatory IUI patients' first rFSH treatment cycle. Dosing according to the nomogram was superior to standard dosing. Trial registration: ClinicalTrials.gov Identifier NCT00374634.

AB - BACKGROUND: Controlled ovarian stimulation (COS) and intrauterine insemination (IUI) are often used as the first-line treatment for subfertile couples. To minimize the variability in ovarian response in patients' first treatment cycle, we recently developed a recombinant follicle-stimulating hormone (rFSH) dosage nomogram. The nomogram has now been tested. METHODS: Multicentre randomized controlled trial (RCT) including 228 ovulatory patients scheduled for COS and IUI. Patients were randomized to 'individual' (50-100 IU rFSH/day, n = 113) or 'standard' (75 IU rFSH/day, n = 115) dose. 'Individual' dose was prescribed according to the nomogram, which was based on patients' body weight and antral follicle count. The primary end-point was the proportion of patients with two to three follicles > or = 14 mm (maximum two follicles > or = 18 mm) on the day of hCG (leading follicle = 18 mm). Primary analysis was made by intention-to-treat. RESULTS: In the 'individual' group, 79/113 (70%) of the patients developed two to three follicles versus 64/115 (56%) in the 'standard' group [absolute difference = 14.3 percentage points; 95% confidence interval (CI) 2-26, P = 0.03; absolute difference = 14.4; 95% CI 2-27, P = 0.02, when adjusting for centre]. Among patients with two to three follicles, the proportion of patients with two follicles was 46/79 (58%) in the 'individual' group versus 34/64 (53%) in the 'standard' group, P = 0.54. Ongoing pregnancy rate was 23/113 (20%) in the 'individual' group and 21/115 (18%) in the 'standard' group and the rate of multiple gestations was 1/113 (1%) versus 5/115 (4%), P = 0.21. CONCLUSIONS: This RCT is the first to clinically test a dosage nomogram in ovulatory IUI patients' first rFSH treatment cycle. Dosing according to the nomogram was superior to standard dosing. Trial registration: ClinicalTrials.gov Identifier NCT00374634.

U2 - 10.1093/humrep/dep239

DO - 10.1093/humrep/dep239

M3 - Journal article

C2 - 19602518

SN - 0268-1161

VL - 24

SP - 2523

EP - 2530

JO - Human Reproduction

JF - Human Reproduction

IS - 10

ER -

Individual versus standard dose of rFSH in a mild stimulation protocol for intrauterine insemination: a randomized study

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