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.
- Conditions
- Intrauterine Insemination (IUI), Infertility, SubfertilityUrological and Genital DiseasesFemale infertility
- Registration Number
- ISRCTN15295216
- Lead Sponsor
- Isala Clinics, Sophia (Isala Klinieken Locatie Sophia) (Netherlands)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 520
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ive birth rate per couple
- Secondary Outcome Measures
Name Time Method 1. Total costs and cost-effectiveness<br>2. Ongoing (>12 weeks amenorrhoea) pregnancy rate per cycle commenced<br>3. Miscarriages (Preclinical miscarriage: spontaneous cessation of a biochemical pregnancy. Early miscarriage: any spontaneous abortion occurring after confirmation of clinical pregnancy and before completed 12 weeks of gestation. Late miscarriage: any spontaneous abortion occurring between completed 12 weeks of gestation and 16 completed weeks of gestation.) and ectopic pregnancies<br>4. Cumulative ongoing pregnancy rates per couple<br>5. Multiple births including the chorionicity<br>6. The occurrence of an LH surge or premature luteinization<br>7. Response of the ovaries to stimulation (number of follicles on day of Ovitrelle administration, speed of development, length of stimulation, quantities of medication used, etc.)