Luteal Phase Progesterone in IUI and Gonadotropin Cycles

Infertility Clinical Trial

Official title:

The Effect of Luteal Phase Support on Pregnancy Rate in Intrauterine Insemination Cycles Following Ovarian Stimulation With Gonadotropins

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01941875
• Other study ID #: Pro00032793
• Status: Completed
• Phase: Phase 3
• Start date: July 2014
• Est. completion date: September 30, 2016

Study information

• Verified date: July 2022
• Source: University of Alberta
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: September 30, 2016
• Est. primary completion date: September 30, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years to 43 Years

Eligibility

Inclusion Criteria:

• Couples with infertility
• Confirmed bilateral tubal patency
• More than 10 million motile sperm available for IUI

Exclusion Criteria:

• Subjects declining enrollment
• Allergies to prescribed vaginal progesterone
• Subjects less than 21 years old or over 43 years old

Related Conditions & MeSH terms

• Infertility

Intervention

Drug:
• Progesterone Effervescent Vaginal Tablets
Experimental

Locations

Country	Name	City	State
Canada	Fertility & Womens Endocrine Clinic, Royal Alexandra Hospital	Edmonton	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
University of Alberta

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical pregnancy rate	Presence of a fetal heart beat after 6 weeks gestational age	After 6 weeks gestational age
Secondary	Biochemical Pregnancy	Biochemical pregnancy rate	After 6 weeks gestational age
Secondary	Non-viable Pregnancy	Non-viable pregnancy rate	After 6 weeks gestational age
Secondary	Multiple Pregnancy	Multiple pregnancy rate	After 6 weeks gestational age