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| Name | Class |
|---|---|
| Merck Serono International SA | INDUSTRY |
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This large prospective multi-center cohort study aims to identify patient's characteristics that significantly influence ovarian response to mild stimulation with a fixed dose of 75 IU recombinant FSH.
A multi-center, open-label, prospective cohorts study. Patients with a regular indication for COH/IUI (controlled ovarian stimulation/ intra uterine insemination) will be asked to participate. Patient's characteristics will be documented including age, weight, BMI, smoking status, cycle day 2 3 or 4 FSH /Estradiol levels, antral follicle count, and AMH. AMH and FSH/Estradiol will be determined centrally after completion of inclusion of all patients in the study. All patients will receive a fixed 75 IU recFSH per day conform normal stimulation protocol starting from cycle day 3, 4 or 5 after exclusion of ovarian cysts by ultrasound. Ovarian response will be documented by ultrasound only. Once the dominant follicle(s) reach a mean diameter of 16-18 mm, hCG (5000IU or 250 mcg) will be applied and insemination will be scheduled 36-42 hours later. Cancellation criteria will be defined according to the national guidelines provided by the NVOG (7).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subfertile couples | Subfertile couples presenting at fertility clinics with an indication for IUI in stimulated cycles All patients will receive a fixed 75 IU recombinant follicle stimulating hormone per day conform normal stimulation protocol starting from cycle day 3, 4 or 5. Once the dominant follicle(s) reach a mean diameter of 16-18 mm, hCG (5000IU or 250 mcg) will be applied and insemination will be scheduled 36-42 hours later. Patients will be followed for the time of one menstrual cycle. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Follicle Stimulating Hormone | Drug | All patients will receive a fixed 75 IU rec follicle stimulating hormone per day subcutaneous injection stimulation protocol starting from cycle day 3, 4 or 5. The intervention done in this study is conform normal stimulation protocol and is not the target of this study. |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the relationship between AMH serum levels and ovarian response | (defined by the number of dominant follicles >15mm) in IUI cycles stimulated with a fixed dose of 75 IU recFSH. All follicles > 11 mm will be documented | one menstrual cycle, one month |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the relationship between age, weight, BMI, smoking, AFC, FSH/E2 on CD3 and ovarian response | (defined by the number of dominant follicles >15mm) in IUI cycles stimulated with a fixed dose of 75 IU recFSH. | one menstrual cycle, one month |
| Pregnancy rate per started cycle. |
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Inclusion Criteria:
Exclusion Criteria:
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Subfertile couples presenting at fertility clinics with an indication for IUI in stimulated cycles
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maaike M Bloemendal, Drs. | Contact | 0031384247506 | m.m.bloemendal@isala.nl | |
| Ben Cohlen, Dr. | Contact | 0031384247570 | b.cohlen@isala.nl |
| Name | Affiliation | Role |
|---|---|---|
| Ben Cohlen, dr. | Isala | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| OLVG | Not yet recruiting | Amsterdam | Po 95500 | 1090 HM | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17943739 | Background | Bensdorp AJ, Cohlen BJ, Heineman MJ, Vandekerckhove P. Intra-uterine insemination for male subfertility. Cochrane Database Syst Rev. 2007 Oct 17;(4):CD000360. doi: 10.1002/14651858.CD000360.pub4. | |
| 17054143 | Background | Verhulst SM, Cohlen BJ, Hughes E, Te Velde E, Heineman MJ. Intra-uterine insemination for unexplained subfertility. Cochrane Database Syst Rev. 2006 Oct 18;(4):CD001838. doi: 10.1002/14651858.CD001838.pub3. |
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| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D005640 | Follicle Stimulating Hormone |
| C571802 | follitropin beta |
| D015292 | Glycoprotein Hormones, alpha Subunit |
| ID | Term |
|---|---|
| D006065 | Gonadotropins, Pituitary |
| D006062 | Gonadotropins |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
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blood sample tested for FSH, E2 and AMH
|
|
From start of the menstrual cycle until a positive heartbeat registered at 12 weeks of gestation. |
| three months |
| Multiple pregnancy rate per started cycle. | From start of the menstrual cycle until positive heartbeats registered at 12 weeks of gestation. | three months |
| Miscarriage rate per started cycle. | miscarriage up to 16 weeks of gestation | five months |
| Cancellation rate per stimulated cycle | one menstrual cycle, one month |
| Isala Klinieken | Recruiting | Zwolle | PO Box 10400 | 8000 GK | Netherlands |
|
| Catharina Ziekenhuis | Not yet recruiting | Eindhoven | PO Box 1350 | 5602 ZA | Netherlands |
|
| AMC | Not yet recruiting | Amsterdam | PO Box 22660 | 1100 DD | Netherlands |
|
| VUMC | Not yet recruiting | Amsterdam | PO Box 7057 | 1007 MB | Netherlands |
|
| UMC Utrecht | Not yet recruiting | Utrecht | PO Box 85500 | 3508 GA | Netherlands |
|
| st Elizabeth Gasthuis | Not yet recruiting | Tilburg | PO Box 90151 | 5000 LC | Netherlands |
|
| 9207576 | Background | Tummon IS, Asher LJ, Martin JS, Tulandi T. Randomized controlled trial of superovulation and insemination for infertility associated with minimal or mild endometriosis. Fertil Steril. 1997 Jul;68(1):8-12. doi: 10.1016/s0015-0282(97)81467-7. |
| 18983747 | Background | Freiesleben NL, Lossl K, Bogstad J, Bredkjaer HE, Toft B, Loft A, Bangsboll S, Pinborg A, Budtz-Jorgensen E, Andersen AN. Predictors of ovarian response in intrauterine insemination patients and development of a dosage nomogram. Reprod Biomed Online. 2008 Nov;17(5):632-41. doi: 10.1016/s1472-6483(10)60310-0. |
| 19602518 | Background | la Cour Freiesleben N, Lossl K, Bogstad J, Bredkjaer HE, Toft B, Rosendahl M, Loft A, Bangsboll S, Pinborg A, Nyboe Andersen A. Individual versus standard dose of rFSH in a mild stimulation protocol for intrauterine insemination: a randomized study. Hum Reprod. 2009 Oct;24(10):2523-30. doi: 10.1093/humrep/dep239. Epub 2009 Jul 14. |
| 20303323 | Background | Freiesleben Nl, Rosendahl M, Johannsen TH, Lossl K, Loft A, Bangsboll S, Friis-Hansen L, Pinborg A, Andersen AN. Prospective investigation of serum anti-Mullerian hormone concentration in ovulatory intrauterine insemination patients: a preliminary study. Reprod Biomed Online. 2010 May;20(5):582-7. doi: 10.1016/j.rbmo.2010.02.007. Epub 2010 Feb 12. |
| 19934213 | Background | Cooper TG, Noonan E, von Eckardstein S, Auger J, Baker HW, Behre HM, Haugen TB, Kruger T, Wang C, Mbizvo MT, Vogelsong KM. World Health Organization reference values for human semen characteristics. Hum Reprod Update. 2010 May-Jun;16(3):231-45. doi: 10.1093/humupd/dmp048. Epub 2009 Nov 24. |
| 19793843 | Background | La Marca A, Sighinolfi G, Radi D, Argento C, Baraldi E, Artenisio AC, Stabile G, Volpe A. Anti-Mullerian hormone (AMH) as a predictive marker in assisted reproductive technology (ART). Hum Reprod Update. 2010 Mar-Apr;16(2):113-30. doi: 10.1093/humupd/dmp036. Epub 2009 Sep 30. |
| 22238112 | Background | Nelson SM, Anderson RA, Broekmans FJ, Raine-Fenning N, Fleming R, La Marca A. Anti-Mullerian hormone: clairvoyance or crystal clear? Hum Reprod. 2012 Mar;27(3):631-6. doi: 10.1093/humrep/der446. Epub 2012 Jan 11. |
| 35460412 | Derived | Rutten A, van Ballegooijen H, Broekmans F, Cohlen B; PRORAILS study group. Insights into ovarian response with a fixed low dose FSH stimulation in an IUI programme: the PRORAILS study. Hum Reprod. 2022 Jun 30;37(7):1440-1450. doi: 10.1093/humrep/deac076. |
| D006730 |
| Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010908 | Pituitary Hormones, Anterior |
| D010907 | Pituitary Hormones |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D006063 | Chorionic Gonadotropin |
| D007986 | Luteinizing Hormone |
| D013972 | Thyrotropin |
| D010926 | Placental Hormones |