The efficacy of GnRH antagonists in cycles with mild ovarian hyperstimulation with recFSH in an intrauterine insemination program. A randomised placebo-controlled double-blinded investigator initiated study.

Isala Clinics, Sophia (Isala Klinieken Locatie Sophia) (Netherlands)0 个研究点目标入组 520 人开始时间: 2006年1月9日最近更新: 2015年1月13日

适应症

试验速览

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•Primary and secondary subfertile patients between 18 and 35 years of age with a diagnosis of unexplained or mild male infertility will be included.
•Definition of unexplained subfertility:
•1. Normozoospermia using the guidelines of the WHO
•2. Patent Fallopian tubes (both ovaries should be in situ)
•3. Cycles varying between 24 and 35 days with an indication of ovulation
•4. No abnormalities at laparoscopy and/or hysterosalpingography
•Information from the post-coital test when performed will only be used for a prognostic model and not as an exclusion criterion.

•1. Age of the woman <18 or >35 years
•2. Duration of subfertility below 2 years
•3. Manifest pathology of the Fallopian tubes
•4. Severe forms of endometriosis (when laparoscopy has been performed: >AFS II)
•5. An average total number of motile spermatozoa during semen analysis (performed twice in case of abnormal findings) below 10 million
•6. Cycle disturbances (where otherwise ovulation induction would be used)
•7. Previous IUI or IVF/ICSI treatment
•8. If an initial ultrasound shows an image of a cyst that is larger than 25 mm treatment will be postponed for 1 month. Persistence of a cyst is a reason for exclusion.
•9. Contraindications for recFSH (Gonal-F), rec-hCG (Ovitrelle) and Cetrotide

发起方

Isala Clinics, Sophia (Isala Klinieken Locatie Sophia) (Netherlands)