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Completed

NCT Number: NCT01941875

Luteal Phase Progesterone in IUI and Gonadotropin Cycles

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.

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Key information

Age range

21 year–43 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Fertility & Womens Endocrine Clinic, Royal Alexandra Hospital

Edmonton, Alberta, T5H 3V9, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Progesterone Effervescent Vaginal Tablets

Drug

Experimental

Other names: Endometrin 100 mg twice daily

Primary outcomes

  1. Clinical pregnancy rate

    Time frame: After 6 weeks gestational age

    Presence of a fetal heart beat after 6 weeks gestational age

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Alberta

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Sep 13, 2013
Registry last updated
Jul 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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