Luteal Phase Progesterone in IUI and Gonadotropin Cycles

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified July 2013 by University of Alberta
Sponsor:
Information provided by (Responsible Party):
University of Alberta
ClinicalTrials.gov Identifier:
NCT01941875
First received: August 19, 2013
Last updated: September 9, 2013
Last verified: July 2013
  Purpose

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 Intervention Phase
Infertility
Drug: Progesterone Effervescent Vaginal Tablets
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University of Alberta:

Primary Outcome Measures:
  • Clinical pregnancy rate [ Time Frame: After 6 weeks gestational age ] [ Designated as safety issue: No ]
    Presence of a fetal heart beat after 6 weeks gestational age


Secondary Outcome Measures:
  • Biochemical Pregnancy [ Time Frame: After 6 weeks gestational age ] [ Designated as safety issue: No ]
    Biochemical pregnancy rate

  • Non-viable Pregnancy [ Time Frame: After 6 weeks gestational age ] [ Designated as safety issue: No ]
    Non-viable pregnancy rate

  • Multiple Pregnancy [ Time Frame: After 6 weeks gestational age ] [ Designated as safety issue: No ]
    Multiple pregnancy rate


Estimated Enrollment: 300
Study Start Date: October 2013
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Endometrin 100 mg twice daily

  Eligibility

Ages Eligible for Study:   21 Years to 43 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01941875

Contacts
Contact: Tarek Motan, MB ChB 780-735-5604 tmotan@ualberta.ca
Contact: Jinglan Han, MD 780-735-5604 jinglan@ualberta.ca

Locations
Canada, Alberta
Fertility & Womens Endocrine Clinic, Royal Alexandra Hospital Not yet recruiting
Edmonton, Alberta, Canada, T5H 3V9
Contact: Tarek Motan, MB ChB    780-735-5604    tmotan@ualberta.ca   
Contact: Jinglan Han, MD    780-735-5604    jinglan@ualberta.ca   
Principal Investigator: Tarek Motan, MB ChB         
Sub-Investigator: Jinglan Han, MD         
Sponsors and Collaborators
University of Alberta
  More Information

No publications provided

Responsible Party: University of Alberta
ClinicalTrials.gov Identifier: NCT01941875     History of Changes
Other Study ID Numbers: Pro00032793
Study First Received: August 19, 2013
Last Updated: September 9, 2013
Health Authority: Canada: Health Canada

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

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female
Progesterone
Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 19, 2014