drugset / Trial / NCT02469805
Stimulated Versus Un-stimulated Intrauterine Insemination Cycles in Couples With Mild Male Factor Infertility
RandomizedParallel-groupOpen-labelTreatment
Summary
Four hundred and fifty women with mild male factor infertility will be divided into 3 equal groups using computer generated random numbers: Group 1 will have up to 4 stimulated IUI cycles, group 2 will have up to 4 unstimulated cycles, women who do not become pregnant after the 4 cycles in groups 1 and 2 will be advised to have regular intercourse at the expected time of ovulation. Group 3 will be the control group will be advised to have regular sexual intercourse at the time of ovulation for 6 months
Timeline
- Start
- 2015-06
- Primary completion
- 2018-06
- Completion
- —
Publications
- Background Cooper TG, Noonan E, von Eckardstein S, Auger J, Baker HW, Behre HM, Haugen TB, Kruger T, Wang C, Mbizvo MT, Vogelsong KM. World Health Organization reference values for human semen characteristics. Hum Reprod Update. 2010 May-Jun;16(3):231-45. doi: 10.1093/humupd/dmp048. Epub 2009 Nov 24.
- Background Quintero RB, Urban R, Lathi RB, Westphal LM, Dahan MH. A comparison of letrozole to gonadotropins for ovulation induction, in subjects who failed to conceive with clomiphene citrate. Fertil Steril. 2007 Oct;88(4):879-85. doi: 10.1016/j.fertnstert.2006.11.166.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Merional | Protein / enzyme biologic | 150 iu | Intramuscular |
| Comparator | human chorionic gonadotropin | Protein / enzyme biologic | 10000 iu | — |