Luteal Phase Progesterone in IUI and Gonadotropin Cycles

Phase 3

Completed

• Conditions: Infertility
• Interventions: Drug: Progesterone Effervescent Vaginal Tablets

• Registration Number: NCT01941875
• Lead Sponsor: University of Alberta

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-08-19
• Study First Submitted QC: 2013-09-09
• Study First Posted: 2013-09-13
• Study Start: 2014-07
• Primary Completion: 2016-09-30
• Study Completion: 2016-09-30
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-14
• Last Update Posted: 2022-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 300

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Luteal Vaginal Progesterone	Progesterone Effervescent Vaginal Tablets	Experiment group: Vaginal progesterone for luteal support beginning the first day after IUI

Primary Outcome Measures

Name	Time	Method
Clinical pregnancy rate	After 6 weeks gestational age	Presence of a fetal heart beat after 6 weeks gestational age

Secondary Outcome Measures

Name	Time	Method
Multiple Pregnancy	After 6 weeks gestational age	Multiple pregnancy rate
Biochemical Pregnancy	After 6 weeks gestational age	Biochemical pregnancy rate
Non-viable Pregnancy	After 6 weeks gestational age	Non-viable pregnancy rate

Trial Locations

Locations (1)

Fertility & Womens Endocrine Clinic, Royal Alexandra Hospital; 🇨🇦 Edmonton, Alberta, Canada