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Luteal Phase Progesterone in IUI and Gonadotropin Cycles

Primary Purpose

Infertility

Status
Completed
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Progesterone Effervescent Vaginal Tablets
Sponsored by
University of Alberta
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility focused on measuring controlled ovarian hyperstimulation, gonadotropins, intrauterine insemination, infertility, luteal progesterone

Eligibility Criteria

21 Years - 43 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Fertility & Womens Endocrine Clinic, Royal Alexandra Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

No Luteal Support

Luteal Vaginal Progesterone

Arm Description

Control group: No luteal phase support or medication will be used

Experiment group: Vaginal progesterone for luteal support beginning the first day after IUI

Outcomes

Primary Outcome Measures

Clinical pregnancy rate
Presence of a fetal heart beat after 6 weeks gestational age

Secondary Outcome Measures

Biochemical Pregnancy
Biochemical pregnancy rate
Non-viable Pregnancy
Non-viable pregnancy rate
Multiple Pregnancy
Multiple pregnancy rate

Full Information

First Posted
August 19, 2013
Last Updated
July 14, 2022
Sponsor
University of Alberta
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1. Study Identification

Unique Protocol Identification Number
NCT01941875
Brief Title
Luteal Phase Progesterone in IUI and Gonadotropin Cycles
Official Title
The Effect of Luteal Phase Support on Pregnancy Rate in Intrauterine Insemination Cycles Following Ovarian Stimulation With Gonadotropins
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
July 2014 (undefined)
Primary Completion Date
September 30, 2016 (Actual)
Study Completion Date
September 30, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Alberta

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
controlled ovarian hyperstimulation, gonadotropins, intrauterine insemination, infertility, luteal progesterone

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Actual)

8. Arms, Groups, and Interventions

Arm Title
No Luteal Support
Arm Type
No Intervention
Arm Description
Control group: No luteal phase support or medication will be used
Arm Title
Luteal Vaginal Progesterone
Arm Type
Experimental
Arm Description
Experiment group: Vaginal progesterone for luteal support beginning the first day after IUI
Intervention Type
Drug
Intervention Name(s)
Progesterone Effervescent Vaginal Tablets
Other Intervention Name(s)
Endometrin 100 mg twice daily
Intervention Description
Experimental
Primary Outcome Measure Information:
Title
Clinical pregnancy rate
Description
Presence of a fetal heart beat after 6 weeks gestational age
Time Frame
After 6 weeks gestational age
Secondary Outcome Measure Information:
Title
Biochemical Pregnancy
Description
Biochemical pregnancy rate
Time Frame
After 6 weeks gestational age
Title
Non-viable Pregnancy
Description
Non-viable pregnancy rate
Time Frame
After 6 weeks gestational age
Title
Multiple Pregnancy
Description
Multiple pregnancy rate
Time Frame
After 6 weeks gestational age

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
43 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Fertility & Womens Endocrine Clinic, Royal Alexandra Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T5H 3V9
Country
Canada

12. IPD Sharing Statement

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Luteal Phase Progesterone in IUI and Gonadotropin Cycles

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