Luteal Phase Progesterone in IUI and Gonadotropin Cycles
This is a study of patients undergoing Controlled Ovarian Hyperstimulation (COH) with Gonadotropins and Intrauterine Insemination (IUI) at a Fertility Clinic.
Infertility is a common problem, and a popular method of therapy is to inject sperm through the cervix and into the uterus, a procedure known as IUI. In conjunction with IUI, injectable medications (gonadotropins) are used to stimulate the ovaries to produce more than one egg per cycle in a process called COH.
Vaginal progesterone is used for luteal support in in vitro fertilization therapy and has been proven to effect pregnancy rates. However, the role of progesterone in COH is still unclear. In this study, the investigators want to examine the effect of giving vaginal progesterone after COH with IUI on pregnancy rates. The investigators want to study if luteal vaginal progesterone results in a higher pregnancy rate compared to no progesterone therapy in COH with IUI. At present, fertility centres vary in the use of progesterone after insemination, most likely due to the lack of studies on this subject.
At the Fertility Clinic all patients undergoing COH with injectable medications and IUI, regardless of whether they are in the study, have a baseline transvaginal ultrasound and blood tests. Patients start the injectable medications for COH until the ovarian follicles are large enough, then a medication to release the eggs is given. The IUI is done approximately 36 hours later. The day after the IUI, study patients will be given vaginal progesterone while the control patients will receive no progesterone. All patients will be followed until a pregnancy test is done and a viable foetus is confirmed by ultrasound.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||The Effect of Luteal Phase Support on Pregnancy Rate in Intrauterine Insemination Cycles Following Ovarian Stimulation With Gonadotropins|
- Clinical pregnancy rate [ Time Frame: After 6 weeks gestational age ] [ Designated as safety issue: No ]Presence of a fetal heart beat after 6 weeks gestational age
- Biochemical Pregnancy [ Time Frame: After 6 weeks gestational age ] [ Designated as safety issue: No ]Biochemical pregnancy rate
- Non-viable Pregnancy [ Time Frame: After 6 weeks gestational age ] [ Designated as safety issue: No ]Non-viable pregnancy rate
- Multiple Pregnancy [ Time Frame: After 6 weeks gestational age ] [ Designated as safety issue: No ]Multiple pregnancy rate
|Study Start Date:||July 2014|
|Estimated Study Completion Date:||January 2016|
|Estimated Primary Completion Date:||September 2015 (Final data collection date for primary outcome measure)|
No Intervention: No Luteal Support
Control group: No luteal phase support or medication will be used
Experimental: Luteal Vaginal Progesterone
Experiment group: Vaginal progesterone for luteal support beginning the first day after IUI
Drug: Progesterone Effervescent Vaginal Tablets
Other Name: Endometrin 100 mg twice daily
Please refer to this study by its ClinicalTrials.gov identifier: NCT01941875
|Contact: Tarek Motan, MB ChBfirstname.lastname@example.org|
|Contact: Jinglan Han, MDemail@example.com|
|Fertility & Womens Endocrine Clinic, Royal Alexandra Hospital||Recruiting|
|Edmonton, Alberta, Canada, T5H 3V9|
|Contact: Tarek Motan, MB ChB 780-735-5604 firstname.lastname@example.org|
|Contact: Jinglan Han, MD 780-735-5604 email@example.com|
|Principal Investigator: Tarek Motan, MB ChB|
|Sub-Investigator: Jinglan Han, MD|