Predicting Ovarian Response in Artificial Insemination With Low Stimulation
NCT ID: NCT01662180
Last Updated: 2012-12-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
510 participants
OBSERVATIONAL
2012-12-31
2015-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
Follicle Stimulating Hormone
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Follicle Stimulating Hormone
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.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Unexplained subfertility including minimal to mild endometriosis (AFS grade 1 or 2) is defined as the failure to conceive after at least one year of unprotected intercourse whereas the standard fertility work-up was unable to detect any factors that might influence fertility negatively.
* semen analysis should be normal according to the WHO guidelines (8),
* ovulation should be documented (by BBT charts, ovulation detection by ultrasound or normal luteal progesterone values),
* tubal patency should be confirmed (HSG, laparoscopy or fertiloscopy) and when a postcoital test was performed a cervical factor should have been excluded.
* Mild male subfertility is defined as abnormal semen parameters according to the WHO (8) but an average total motile sperm account before processing of at least 10 million.
Exclusion Criteria
* Endometriosis AFS grade 3 or 4
* Contra-indications for the use of gonadotrophins (cysts larger than 2 cm, allergy for gonadotrophins)
* Total motile sperm count after sperm processing below 1 million
* Women aged younger than eighteen years or older than 45 years.
* Previous treatment with COH/IUI for treating current subfertility
* Unable to speak or read the Dutch language
18 Years
45 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Merck Serono International SA
INDUSTRY
Isala
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
M. Bloemendal
drs.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Ben Cohlen, dr.
Role: PRINCIPAL_INVESTIGATOR
Isala
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
OLVG
Amsterdam, Po 95500, Netherlands
Isala Klinieken
Zwolle, PO Box 10400, Netherlands
Catharina Ziekenhuis
Eindhoven, PO Box 1350, Netherlands
AMC
Amsterdam, PO Box 22660, Netherlands
VUMC
Amsterdam, PO Box 7057, Netherlands
UMC Utrecht
Utrecht, PO Box 85500, Netherlands
st Elizabeth Gasthuis
Tilburg, PO Box 90151, Netherlands
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Eugenie Kaaijk, dr.
Role: primary
Sabine Logtenberg
Role: backup
Maaike Bloemendal, Drs.
Role: primary
Henriette Hulsebos
Role: backup
Minouche van Rumste, dr.
Role: primary
Milou Peters
Role: backup
Fulco van der Veen, prof. dr.
Role: primary
Tessa de Vries
Role: backup
Cornelis Lambalk, prof. dr.
Role: primary
Angelique de Vos-Brouwer
Role: backup
Frank Broekmans, prof. dr.
Role: primary
Marian Kosterman
Role: backup
Jesper Smeenk, dr.
Role: primary
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
PRORAILS trial
Identifier Type: -
Identifier Source: org_study_id