Stimulated Versus Un-stimulated Intrauterine Insemination Cycles in Couples With Mild Male Factor Infertility
1 other identifier
interventional
450
1 country
2
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2015
CompletedFirst Submitted
Initial submission to the registry
June 9, 2015
CompletedFirst Posted
Study publicly available on registry
June 11, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2018
CompletedJanuary 3, 2018
December 1, 2017
3 years
June 9, 2015
December 29, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Ongoing pregnancy rate
12 weeks after IUI or timed sexual intercourse
Study Arms (3)
stimulated intrauterine insemination (IUI)
ACTIVE COMPARATOROn the 3rd day of menstruation women in group 1 will have a vaginal ultrasound and will receive daily intramuscular 150 IU of human menopausal gonadotropins starting from the 3rd day of menstruation. On day 8 the ultrasound will be repeated and serum E2 will be measured, hMG dose will be adjusted and continued and the frequency of ultrasound scans will be individualized. HMG will be stopped when at least 2 follicles measuring 18 mm are associated with serum E2 of 500-3000 Pg/mL, this was followed by the administration of 10000 IU of human chorionic gonadotropin
Unstimulated IUI
ACTIVE COMPARATORWomen in group 2 will be asked to test their morning urine specimen for luteinizing hormone daily starting 4 days before the expected day of ovulation. This will be done using a qualitative kit. IUI will be performed on the day after the surge in urinary excretion of luteinizing hormone.
Control group
ACTIVE COMPARATORWomen will be asked to test their urine for luteinizing hormone by the same method as group 2. They will be asked to have an intercourse on the day after the surge in urinary excretion of luteinizing hormone and this will be repeated for 12 months.
Interventions
On the 3rd day of menstruation women will have a vaginal ultrasound and will receive daily intramuscular 150 IU of human menopausal gonadotropins (hMG, Merional ®, IBSA, Lugano, Switzerland) starting from the 3nd day of menstruation.
Administration of 10000 IU of human chorionic gonadotropin (hCG; Choriomon®, IBSA) when at least 2 follicles measuring 18 mm are observed during vaginal ultrasound and is associated with serum E2 of 500-3000 Pg/mL.
Semen will be processed and drawn into a shepherd catheter attached to a 1 mL syringe and injected into the uterus
Women will be asked to test their morning urine specimen for luteinizing hormone daily starting 4 days before the expected day of ovulation. This will be done using a qualitative kit
Processes semen will be drawn into a shepherd catheter attached to a 1 mL syringe and injected into the uterus
Eligibility Criteria
You may qualify if:
- Mild male factor infertility defined as meaning two or more semen analyses that have one or more variables which fall below the 5th centile as defined by the World Health Organization, and where the effect on the chance of pregnancy occurring naturally through vaginal intercourse within a period of 24 months would then be similar to people with unexplained infertility or mild endometriosis.
You may not qualify if:
- Known allergy to FSH
- Other factors of infertility.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Study Sites (2)
BeniSuef University hospitals
BeniSuef, Egypt
Cairo university hospitals
Cairo, Egypt
Related Publications (2)
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.
PMID: 19934213BACKGROUNDQuintero 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.
PMID: 17920403BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Lecturer of Gynecology and Obstetrics
Study Record Dates
First Submitted
June 9, 2015
First Posted
June 11, 2015
Study Start
June 1, 2015
Primary Completion
June 1, 2018
Last Updated
January 3, 2018
Record last verified: 2017-12