Ovarian stimulation with delayed start of r-hFSH in IVF treatment in subjects at increased risk of OHSS. - Delayed start of r-hFSH in subjects at risk of OHSS.

• Conditions: Subjects at increased risk of ovarian hyperstimulation syndrome (OHSS).

• Registration Number: EUCTR2010-021362-29-FI
• Lead Sponsor: Helsingin Lääkärikeskus Oy, Graviditas Lapsettomuusklinikka

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-08-09
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

1. Indication for in vitro fertilisation treatment (IVF)
2. Increased risk of moderate or severe ovarian hyperstimulation syndrome (OHSS) because of polycystic ovary (PCO) or multifollicular ovary (MFO) (ten or more antral follicles in one ovary seen in transvaginal ultrasound (TVU) or because of symptoms or signs of an increased risk of moderate or severe OHSS in previous ovarian stimulations
3. Women aged 18-38
4. Subject is willing and able to participate in the trial and has signed an informed consent form before undergoing any study related activities

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Pregnancy; 2. History of current disease or concomitant medication known to harm IVF treatment or subsequent pregnancy; 3. More than three previous IVF cycles without conception; 4. BMI >30 kg/m2; 5. Subject’s partner has a severe sperm damage (sperm count < 5 million/ml). (Donated sperm can be used instead)
6. Contraindications of follitropin alfa as defined in the Summary of Product Characteristics (SPC); 7. Allergy to Gonal-f®, clomiphene citrate, Cetrotide® or Ovitrelle® or to any component of these medicines; 8. Current or past (within the last 2 years) abuse of alcohol or narcotics; 9. Ovarian cyst over 30mm at screening visit; 10. Ovarian stimulation for IVF treatment within 30 days before the screening visit; 11.Diabetes, epilepsy, cardiovascular disease, HIV infection; 12. Agents known to affect ovulation (e.g. neuroleptics), drugs known or suspected to be teratogenic which are not routinely used for any of the ART procedures; 13. Blood pressure over 140/90 mmHg; 14. Serum gonadotropin levels (FSH < 3.5 IU/l or > 12IU/l; LH < 2.4 IU/l); 15. Hyperprolactinemia (serum prolactin level > 496 mIU/l)
16. Any other condition, circumstance or previous medication that, in the opinion of the investigator, could compromise the subject’s ability to comply with the study protocol.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified