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Predicting Ovarian Response in Artificial Insemination With Low Stimulation

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by Isala Klinieken
Sponsor:
Collaborator:
Merck Serono International SA
Information provided by (Responsible Party):
M. Bloemendal, Isala Klinieken
ClinicalTrials.gov Identifier:
NCT01662180
First received: July 26, 2012
Last updated: December 12, 2012
Last verified: December 2012
  Purpose

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.


Condition Intervention
Subfertility
Drug: Follicle Stimulating Hormone

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Predicting Ovarian Response in Artificial Insemination With Low Stimulation

Further study details as provided by Isala Klinieken:

Primary Outcome Measures:
  • To assess the relationship between AMH serum levels and ovarian response [ Time Frame: one menstrual cycle, one month ] [ Designated as safety issue: No ]
    (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


Secondary Outcome Measures:
  • To assess the relationship between age, weight, BMI, smoking, AFC, FSH/E2 on CD3 and ovarian response [ Time Frame: one menstrual cycle, one month ] [ Designated as safety issue: No ]
    (defined by the number of dominant follicles >15mm) in IUI cycles stimulated with a fixed dose of 75 IU recFSH.

  • Pregnancy rate per started cycle. [ Time Frame: three months ] [ Designated as safety issue: No ]
    From start of the menstrual cycle until a positive heartbeat registered at 12 weeks of gestation.

  • Multiple pregnancy rate per started cycle. [ Time Frame: three months ] [ Designated as safety issue: No ]
    From start of the menstrual cycle until positive heartbeats registered at 12 weeks of gestation.

  • Miscarriage rate per started cycle. [ Time Frame: five months ] [ Designated as safety issue: No ]
    miscarriage up to 16 weeks of gestation

  • Cancellation rate per stimulated cycle [ Time Frame: one menstrual cycle, one month ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

blood sample tested for FSH, E2 and AMH


Estimated Enrollment: 510
Study Start Date: December 2012
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

Drug: 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 Names:
  • Puregon [Merck Sharp & Dohme bv]
  • Gonal -F [Serono Benelux bv]

Detailed Description:

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).

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Subfertile couples presenting at fertility clinics with an indication for IUI in stimulated cycles

Criteria

Inclusion Criteria:

  • couples with unexplained or mild male subfertility (1-3) and a spontaneous chance of conception below 40% (Hunault score).
  • 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:

  • Hunault score ≥ 40%
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01662180

Contacts
Contact: Maaike M Bloemendal, Drs. 0031384247506 m.m.bloemendal@isala.nl
Contact: Ben Cohlen, Dr. 0031384247570 b.cohlen@isala.nl

Locations
Netherlands
OLVG Not yet recruiting
Amsterdam, Po 95500, Netherlands, 1090 HM
Contact: Eugenie Kaaijk, dr.    0031205993481    e.m.kaaijk@olvg.nl   
Contact: Sabine Logtenberg    003120-5999111    s.l.m.logtenberg@olvg.nl   
Principal Investigator: Eugenie Kaaijk, dr.         
Isala Klinieken Recruiting
Zwolle, PO Box 10400, Netherlands, 8000 GK
Contact: Maaike Bloemendal, Drs.    0031384247506    m.m.bloemendal@isala.nl   
Contact: Henriette Hulsebos    0031384247783    h.j.m.hulsebos@isala.nl   
Principal Investigator: Ben Cohlen, dr.         
Catharina Ziekenhuis Not yet recruiting
Eindhoven, PO box 1350, Netherlands, 5602 ZA
Contact: Minouche van Rumste, dr.    003140 239 71 00    minouche.v.rumste@catharinaziekenhuis.nl   
Contact: Milou Peters    00316-5102 8887    milou.peters@catharinaziekenhuis.nl   
Principal Investigator: Minouche van Rumste, dr.         
AMC Not yet recruiting
Amsterdam, PO box 22660, Netherlands, 1100 DD
Contact: Fulco van der Veen, prof. dr.    003120 - 566 4287    f.vanderveen@amc.uva.nl   
Contact: Tessa de Vries    00316 - 23799274    t.s.devries@amc.uva.nl   
Principal Investigator: Fulco van der Veen, prof. dr.         
VUMC Not yet recruiting
Amsterdam, PO box 7057, Netherlands, 1007 MB
Contact: Cornelis Lambalk, prof. dr.    0031204444444    cb.lambalk@vumc.nl   
Contact: Angelique de Vos-Brouwer    003120-4442180    m.devos-brouwer@vumc.nl   
Principal Investigator: Cornelis Lambalk, prof. dr.         
UMC Utrecht Not yet recruiting
Utrecht, PO box 85500, Netherlands, 3508 GA
Contact: Frank Broekmans, prof. dr.    088-7551041    f.broekmans@umcutrecht.nl   
Contact: Marian Kosterman    088-7555555    M.J.T.Kosterman@umcutrecht.nl   
Principal Investigator: Frank Broekmans, prof. dr.         
st Elizabeth Gasthuis Not yet recruiting
Tilburg, PO box 90151, Netherlands, 5000 LC
Contact: Jesper Smeenk, dr.    0031013539 30 06    j.smeenk@elizabeth.nl   
Principal Investigator: Jesper Smeenk, dr.         
Sponsors and Collaborators
Isala Klinieken
Merck Serono International SA
Investigators
Principal Investigator: Ben Cohlen, dr. Isala Klinieken
  More Information

Additional Information:
Publications:

Responsible Party: M. Bloemendal, drs., Isala Klinieken
ClinicalTrials.gov Identifier: NCT01662180     History of Changes
Other Study ID Numbers: PRORAILS trial
Study First Received: July 26, 2012
Last Updated: December 12, 2012
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by Isala Klinieken:
subfertility, IUI, rec FSH, FSH, E2, AMH

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female
Hormones
Follicle Stimulating Hormone
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014