InfertilityPhase 4NCT03115320
Frozen-thawed Embryo Transfer in a Natural Cycle: hCG Triggering Versus LH Home Test
A Phase 4 study testing Human chorionic gonadotropin and Home ovulation test in people with Infertility, run by Tampere University Hospital at 1 site in Finland.
Trial summary
The primary aim of this study is to find out if ovulation triggered with hCG provides any additional benefit in comparison to spontaneous LH surge measured with the LH surge home test when transferring frozen-thawed embryo in a natural cycle. Read more about this study
- Who is it for?
- Ages 18 to 42 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- Human chorionic gonadotropin and Home ovulation test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteFinland
- Study dates
- Jan 2017to Dec 2019
- Phase
- Phase 4
- 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 18 to 42 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- - Patient with IVF or ICSI cycle and therefore having frozen-thawed embryos
- Regular menstruation cycle
- Patient's willingness to participate in the study
Who cannot join
- - Irregular menstrual cycle demanding preparing endometrium with hormones for frozen-thawed embryo
- No frozen embryos after IVF cycle
- Allergy to Pregnyl® or some of its ingredients in the medication or other contraindications due to Pregnyl®
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Protocol for a Randomized, Two-Parallel-group Study to Compare the Efficacy of Testing LH Surge at Home Versus Medically Triggered Ovulation With hCG (Pregnyl®) in the Naturally Stimulated Cycle in the Frozen-thawed Embryo Transfer
The primary aim of this study is to find out if ovulation triggered with hCG provides any additional benefit in comparison to spontaneous LH surge measured with the LH surge home test when transferring frozen-thawed embryo in a natural cycle.
Read the detailed description
The aim of this study is to find out the best method for the ovulation triggering. We study the live birth rates in the both groups.
- Conditions
- Infertility
- Being tested
- Human chorionic gonadotropin, Home ovulation test
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Human chorionic gonadotropinDrug
Also called Home ovulation test
Human chorionic gonadotropin (Pregnyl, 5000IU) is used in the medication group to confirme the ovulation.
Home ovulation testOther
The ovulation in the natural menstrual cycle is confirmed by the home ovulation tests from the urine.
| Study group | Role | What they receive |
|---|---|---|
| Pregnyl (Human chorionic gonadotropin) | Experimental | In this group, patients have natural cycle in frozen-thawed embryo transfer and the ovulation is confirmed by administration of hCG (Pregnyl® 5000 IU). The day of transferring embryo is depending on the day of administration of hCG and the age of the embryo. The day zero day is defined by ovulation triggered by hCG. Receives: Drug: Human chorionic gonadotropin |
| Home ovulation test | Other | The patients randomized to the LH surge group perform the ovulation home test daily from the urine. Thus, the ovulation in this group is corfimed by the urine test. The day of transferring embryo is depending on the positive ovulation test and the age of the embryo. The day zero day is defined by positive ovulation test. Receives: Other: Home ovulation test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Live birth rate
Live birth rate
Measured: At possible delivery (about 40 weeks)
Secondary outcomes (1)
Ongoing pregnancy rate
Ongoing pregnancy rate
Measured: After two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2017
- Study startJan 2017
- Primary completionNov 2019
- Study completionDec 2019
Why it stopped: High cancellation rate in LH test group in interim analysis
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.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tampere University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Helena Tinkanen, Principal investigator, Tampere University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03115320
- Sponsor's protocol ID
- R16172M
- Other IDs
- 2016-003959-29, 2016
- Status last verified
- May 2020
- First submitted
- 17 Nov 2016
- Last updated
- 22 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Protocol for a Randomized, Two-Parallel-group Study to Compare the Efficacy of Testing LH Surge at Home Versus Medically Triggered Ovulation With hCG (Pregnyl®) in the Naturally Stimulated Cycle in the Frozen-thawed Embryo Transfer
- ClinicalTrials.gov ID
- NCT03115320
- Acronym / sponsor ID
- R16172M
- Conditions
- Infertility
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: High cancellation rate in LH test group in interim analysis
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Tampere University HospitalUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- Nov 2019 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 14 Apr 2017 (actual)
- 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.
The primary aim of this study is to find out if ovulation triggered with hCG provides any additional benefit in comparison to spontaneous LH surge measured with the LH surge home test when transferring frozen-thawed embryo in a natural cycle.
Detailed description
The aim of this study is to find out the best method for the ovulation triggering. We study the live birth rates in the both groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pregnyl (Human chorionic gonadotropin) | Experimental | Drug: Human chorionic gonadotropinIn this group, patients have natural cycle in frozen-thawed embryo transfer and the ovulation is confirmed by administration of hCG (Pregnyl® 5000 IU). The day of transferring embryo is depending on the day of administration of hCG and the age of the embryo. The day zero day is defined by ovulation triggered by hCG. |
| Home ovulation test | Other | Other: Home ovulation testThe patients randomized to the LH surge group perform the ovulation home test daily from the urine. Thus, the ovulation in this group is corfimed by the urine test. The day of transferring embryo is depending on the positive ovulation test and the age of the embryo. The day zero day is defined by positive ovulation test. |
Who may qualify
- Ages
- 18 to 42 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- - Patient with IVF or ICSI cycle and therefore having frozen-thawed embryos
- Regular menstruation cycle
- Patient's willingness to participate in the study
Key exclusion criteria (3 listed)
- - Irregular menstrual cycle demanding preparing endometrium with hormones for frozen-thawed embryo
- No frozen embryos after IVF cycle
- Allergy to Pregnyl® or some of its ingredients in the medication or other contraindications due to Pregnyl®
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 |
|---|---|---|
| Human chorionic gonadotropinAlso: Home ovulation testHuman chorionic gonadotropin (Pregnyl, 5000IU) is used in the medication group to confirme the ovulation. | Drug | Pregnyl (Human chorionic gonadotropin) |
| Home ovulation testThe ovulation in the natural menstrual cycle is confirmed by the home ovulation tests from the urine. | Other | Home ovulation test |
Primary outcome
Live birth rate
Time frame: At possible delivery (about 40 weeks)
Live birth rate
1 secondary outcome
Ongoing pregnancy rate
Time frame: After two weeks
Results and safety
The study was stopped early (reason given: High cancellation rate in LH test group in interim analysis). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2024.
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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.
Helena Tinkanen principal investigator
Tampere University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Human chorionic gonadotropin and Home ovulation test in people with Infertility, run by Tampere University Hospital at 1 site in Finland.
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: stopped early, as of the sponsor's last update on 22 Aug 2024. 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 Finland. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 was stopped early (reason given: High cancellation rate in LH test group in interim analysis). Results are not available in the source record.
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?
Live birth rate (time frame: At possible delivery (about 40 weeks)). 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 22 Aug 2024.