Eligible for consideration are couples who are primarily undesirably non-pregnant and for whom an IUI procedure is suggested as a viable treatment option. A routine fertility check-up as defined, for instance, in the guidelines of the Dutch Society of Obstetrics and Gynaecology will be performed in this study. This defines the concepts of subfertility, previous history, physical examination (in this study including recording of the height and weight), laboratory tests and fertility work-up.
Conditions
Interventions
The research group of patients will consist of two arms:
one group will receive ovarian stimulation with recFSH combined with placebo (the recFSH group)
and one group will receive recFSH combined wi
Sponsors
none
Serono Benelux B.V. will provide all centres with the necessary drugs
Eligibility
Inclusion criteria
Inclusion criteria: Primary and secondary subfertile patients between 18 and 35 years of age with a diagnosis of unexplained or mild male infertility (see above) will be included. Definition of unexplained subfertility: normozoospermia using the guidelines of the WHO; patent Fallopian tubes (both ovaries should be in situ); cycles varying between 24 and 35 days with an indication of ovulation; 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.
Exclusion criteria
Exclusion criteria: 1. Age of the woman 35 years; 2. Duration of subfertility below 2 years; 3. Manifest pathology of the Fallopiantubes; 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Live birth rate per couple. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Total costs and cost-effectiveness; 2. Ongoing (> 12 weeks amenorrhoea) pregnancy rate per cycle commenced; 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; 4. Cumulative ongoing pregnancy rates per couple; 5. Multiple births including the chorionicity; 6. The occurrence of an LH surge or premature luteinization; 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.). | — |
Contacts
Public ContactB.J. Cohlen
Isala Clinics Zwolle, Location Sophia, Department of Reproductive Medicine, Division of Obstretrics and Gynaecology, P.O. Box 10400
Outcome results
None listed