Luteal Phase Progesterone in IUI and Gonadotropin Cycles
|ClinicalTrials.gov Identifier: NCT01941875|
Recruitment Status : Unknown
Verified July 2013 by University of Alberta.
Recruitment status was: Recruiting
First Posted : September 13, 2013
Last Update Posted : January 1, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Infertility||Drug: Progesterone Effervescent Vaginal Tablets||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Effect of Luteal Phase Support on Pregnancy Rate in Intrauterine Insemination Cycles Following Ovarian Stimulation With Gonadotropins|
|Study Start Date :||July 2014|
|Estimated Primary Completion Date :||September 2015|
|Estimated Study Completion Date :||January 2016|
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
- Clinical pregnancy rate [ Time Frame: After 6 weeks gestational age ]Presence of a fetal heart beat after 6 weeks gestational age
- Biochemical Pregnancy [ Time Frame: After 6 weeks gestational age ]Biochemical pregnancy rate
- Non-viable Pregnancy [ Time Frame: After 6 weeks gestational age ]Non-viable pregnancy rate
- Multiple Pregnancy [ Time Frame: After 6 weeks gestational age ]Multiple pregnancy rate
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|