Luteal Phase Progesterone in IUI and Gonadotropin Cycles

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

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 Overview

• Status: Completed
• Conditions: Infertility
• Intervention / Treatment: Drug: Progesterone Effervescent Vaginal Tablets

• Study Type: Interventional
• Enrollment (Actual): 300
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T5H 3V9
      • Fertility & Womens Endocrine Clinic, Royal Alexandra Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 43 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; Experimental; Other Names: Endometrin 100 mg twice daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical pregnancy rate	Presence of a fetal heart beat after 6 weeks gestational age	After 6 weeks gestational age

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biochemical Pregnancy	Biochemical pregnancy rate	After 6 weeks gestational age
Non-viable Pregnancy	Non-viable pregnancy rate	After 6 weeks gestational age
Multiple Pregnancy	Multiple pregnancy rate	After 6 weeks gestational age

Collaborators and Investigators

• Sponsor: University of Alberta

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (ACTUAL): September 30, 2016
• Study Completion (ACTUAL): September 30, 2016

Study Registration Dates

• First Submitted: August 19, 2013
• First Submitted That Met QC Criteria: September 9, 2013
• First Posted (ESTIMATE): September 13, 2013

Study Record Updates

• Last Update Posted (ACTUAL): July 18, 2022
• Last Update Submitted That Met QC Criteria: July 14, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: infertility; controlled ovarian hyperstimulation; intrauterine insemination; gonadotropins; luteal progesterone
• Additional Relevant MeSH Terms: Infertility; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Progestins; Progesterone
• Other Study ID Numbers: Pro00032793