InfertilityPhase 3NCT01941875
Luteal Phase Progesterone in IUI and Gonadotropin Cycles
A Phase 3 study testing Progesterone Effervescent Vaginal Tablets in people with Infertility, run by University of Alberta at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 43 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility
- What is being tested?
- Progesterone Effervescent Vaginal Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2014to 30 Sep 2016
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 43 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Couples with infertility
- Confirmed bilateral tubal patency
- More than 10 million motile sperm available for IUI
Who cannot join
- Subjects declining enrollment
- Allergies to prescribed vaginal progesterone
- Subjects less than 21 years old or over 43 years old
Trial locations and contacts
1 site in 1 country.
Canada1 site
Fertility & Womens Endocrine Clinic, Royal Alexandra Hospital
Edmonton, Alberta, T5H 3V9
About this study
Official title: 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.
Read more
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.
- Conditions
- Infertility
- Being tested
- Progesterone Effervescent Vaginal Tablets
- Keywords
- controlled ovarian hyperstimulation, gonadotropins, intrauterine insemination, infertility, luteal progesterone
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Progesterone Effervescent Vaginal TabletsDrug
Also called Endometrin 100 mg twice daily
Experimental
| Study group | Role | What they receive |
|---|---|---|
| No Luteal Support | No intervention | Control group: No luteal phase support or medication will be used |
| Luteal Vaginal Progesterone | Experimental | Experiment group: Vaginal progesterone for luteal support beginning the first day after IUI Receives: Drug: Progesterone Effervescent Vaginal Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical pregnancy rate
Presence of a fetal heart beat after 6 weeks gestational age
Measured: After 6 weeks gestational age
Secondary outcomes (3)
Biochemical Pregnancy
Biochemical pregnancy rate
Measured: After 6 weeks gestational age
Non-viable Pregnancy
Non-viable pregnancy rate
Measured: After 6 weeks gestational age
Multiple Pregnancy
Multiple pregnancy rate
Measured: After 6 weeks gestational age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2013 (estimated)
- Study startJul 2014
- Primary completion30 Sep 2016
- Study completion30 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01941875
- Sponsor's protocol ID
- Pro00032793
- Status last verified
- Jul 2022
- First submitted
- 19 Aug 2013
- Last updated
- 18 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Luteal Phase Support on Pregnancy Rate in Intrauterine Insemination Cycles Following Ovarian Stimulation With Gonadotropins
- ClinicalTrials.gov ID
- NCT01941875
- Acronym / sponsor ID
- Pro00032793
- Conditions
- Infertility
- Keywords
- controlled ovarian hyperstimulation, gonadotropins, intrauterine insemination, infertility, luteal progesterone
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- 30 Sep 2016 (actual)
- Study completion
- 30 Sep 2016 (actual)
- First posted
- 13 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No Luteal Support | No intervention | –Control group: No luteal phase support or medication will be used |
| Luteal Vaginal Progesterone | Experimental | Drug: Progesterone Effervescent Vaginal TabletsExperiment group: Vaginal progesterone for luteal support beginning the first day after IUI |
Who may qualify
- Ages
- 21 to 43 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Couples with infertility
- Confirmed bilateral tubal patency
- More than 10 million motile sperm available for IUI
Key exclusion criteria (3 listed)
- Subjects declining enrollment
- Allergies to prescribed vaginal progesterone
- Subjects less than 21 years old or over 43 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Progesterone Effervescent Vaginal TabletsAlso: Endometrin 100 mg twice dailyExperimental | Drug | Luteal Vaginal Progesterone |
Primary outcome
Clinical pregnancy rate
Time frame: After 6 weeks gestational age
Presence of a fetal heart beat after 6 weeks gestational age
3 secondary outcomes
Biochemical Pregnancy
Time frame: After 6 weeks gestational age
Non-viable Pregnancy
Time frame: After 6 weeks gestational age
Multiple Pregnancy
Time frame: After 6 weeks gestational age
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Progesterone Effervescent Vaginal Tablets in people with Infertility, run by University of Alberta at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical pregnancy rate (time frame: After 6 weeks gestational age). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2022.