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Predicting Ovarian Response in Artificial Insemination With Low Stimulation

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2012 by Isala.
Recruitment status was:  Recruiting
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

Resource links provided by NLM:


Further study details as provided by Isala:

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   (Adult)
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

Locations
Netherlands
OLVG
Amsterdam, Po 95500, Netherlands, 1090 HM
Isala Klinieken
Zwolle, PO Box 10400, Netherlands, 8000 GK
Catharina Ziekenhuis
Eindhoven, PO box 1350, Netherlands, 5602 ZA
AMC
Amsterdam, PO box 22660, Netherlands, 1100 DD
VUMC
Amsterdam, PO box 7057, Netherlands, 1007 MB
UMC Utrecht
Utrecht, PO box 85500, Netherlands, 3508 GA
st Elizabeth Gasthuis
Tilburg, PO box 90151, Netherlands, 5000 LC
Sponsors and Collaborators
Isala
Merck Serono International SA
Investigators
Principal Investigator: Ben Cohlen, dr. Isala
  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:
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

ClinicalTrials.gov processed this record on December 07, 2016