Luteal Phase Progesterone in IUI and Gonadotropin Cycles

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Infertility Drug: Progesterone Effervescent Vaginal Tablets Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Infertility
U.S. FDA Resources

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
Other Name: Endometrin 100 mg twice daily

Primary Outcome Measures :
  1. Clinical pregnancy rate [ Time Frame: After 6 weeks gestational age ]
    Presence of a fetal heart beat after 6 weeks gestational age

Secondary Outcome Measures :
  1. Biochemical Pregnancy [ Time Frame: After 6 weeks gestational age ]
    Biochemical pregnancy rate

  2. Non-viable Pregnancy [ Time Frame: After 6 weeks gestational age ]
    Non-viable pregnancy rate

  3. Multiple Pregnancy [ Time Frame: After 6 weeks gestational age ]
    Multiple pregnancy rate

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 43 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01941875

Contact: Tarek Motan, MB ChB 780-735-5604
Contact: Jinglan Han, MD 780-735-5604

Canada, Alberta
Fertility & Womens Endocrine Clinic, Royal Alexandra Hospital Recruiting
Edmonton, Alberta, Canada, T5H 3V9
Contact: Tarek Motan, MB ChB    780-735-5604   
Contact: Jinglan Han, MD    780-735-5604   
Principal Investigator: Tarek Motan, MB ChB         
Sub-Investigator: Jinglan Han, MD         
Sponsors and Collaborators
University of Alberta

Responsible Party: University of Alberta Identifier: NCT01941875     History of Changes
Other Study ID Numbers: Pro00032793
First Posted: September 13, 2013    Key Record Dates
Last Update Posted: January 1, 2015
Last Verified: July 2013

Keywords provided by University of Alberta:
controlled ovarian hyperstimulation
intrauterine insemination
luteal progesterone

Additional relevant MeSH terms:
Genital Diseases, Male
Genital Diseases, Female
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs