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Clinical Trials/NCT01941875
NCT01941875
Completed
Phase 3

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

University of Alberta1 site in 1 country300 target enrollmentJuly 2014

Overview

Phase
Phase 3
Intervention
Progesterone Effervescent Vaginal Tablets
Conditions
Infertility
Sponsor
University of Alberta
Enrollment
300
Locations
1
Primary Endpoint
Clinical pregnancy rate
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 2014
End Date
September 30, 2016
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Sponsor

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

Arms & Interventions

Luteal Vaginal Progesterone

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

Intervention: Progesterone Effervescent Vaginal Tablets

Outcomes

Primary Outcomes

Clinical pregnancy rate

Time Frame: After 6 weeks gestational age

Presence of a fetal heart beat after 6 weeks gestational age

Secondary Outcomes

  • Multiple Pregnancy(After 6 weeks gestational age)
  • Non-viable Pregnancy(After 6 weeks gestational age)
  • Biochemical Pregnancy(After 6 weeks gestational age)

Study Sites (1)

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