InfertilityPhase 4GnRHa triggerNCT01980680
The Exogenous Progesterone Free Luteal Phase After GnRHa Trigger - a Pilot Study in Normo-responder IVF Patients
A Phase 4 study testing hCG and Progesterone and Estradiol in people with Infertility, run by Peter Humaidan at 1 site in Denmark.
Trial summary
After hCG trigger a large amount of exogenous progesterone is used for luteal phase support in many countries until 10th week of gestation. Instead we suggest the use of two small doses of hCG after the trigger during the early luteal phase after GnRHa trigger, promoting the endogenous progesterone production from the… Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- hCG and Progesterone and Estradiol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteDenmark
- Study dates
- Dec 2014to May 2020
- 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 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age between 20 and 40
- Normal menstrual cycles: 25-34 days
- Oligomenorrhea/amenorrhea or polycystic syndrome (defined according to the Rotterdam criteria 2004)
- BMI >18 and <35 kg/m2
Who cannot join
- Patients with >14 follicles on day of trigger
- Previous hyperresponse with OHSS development
- Previous low response (less than 3 oocytes on a high dose of FSH stimulation)
- Endocrine disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Exogenous Progesterone Free Luteal Phase After GnRHa Trigger - a Randomized Controlled Pilot Study in Normo-responder IVF Patients
After hCG trigger a large amount of exogenous progesterone is used for luteal phase support in many countries until 10th week of gestation. Instead we suggest the use of two small doses of hCG after the trigger during the early luteal phase after GnRHa trigger, promoting the endogenous progesterone production from the corpora lutea (CL).
- Conditions
- Infertility
- Being tested
- hCG, Progesterone and Estradiol
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hCGDrug
Progesterone and EstradiolDrug
| Study group | Role | What they receive |
|---|---|---|
| Agonist trigger | Experimental | Agonist trigger Buserelin 0,5 mg and Pregnyl (hCG) Receives: Drug: hCG |
| hCG | Active comparator | hCG trigger Pregnyl (hCG) and Progesterone and Estradiol Receives: Drug: Progesterone and Estradiol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ongoing pregnancy rate per patient
Measured: 10th week of gestation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2013 (estimated)
- Study startDec 2014
- Primary completionSep 2019
- Study completionMay 2020
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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peter Humaidan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Peter Humaidan, Regionshospitalet Viborg, Skive
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01980680
- Sponsor's protocol ID
- Agonist5
- Acronym
- GnRHa trigger
- Status last verified
- Dec 2020
- First submitted
- 28 Oct 2013
- Last updated
- 17 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Exogenous Progesterone Free Luteal Phase After GnRHa Trigger - a Randomized Controlled Pilot Study in Normo-responder IVF Patients
- ClinicalTrials.gov ID
- NCT01980680
- Acronym / sponsor ID
- GnRHa trigger / Agonist5
- Conditions
- Infertility
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Peter HumaidanUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Sep 2019 (actual)
- Study completion
- May 2020 (actual)
- First posted
- 11 Nov 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.
After hCG trigger a large amount of exogenous progesterone is used for luteal phase support in many countries until 10th week of gestation. Instead we suggest the use of two small doses of hCG after the trigger during the early luteal phase after GnRHa trigger, promoting the endogenous progesterone production from the corpora lutea (CL).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Agonist trigger | Experimental | Drug: hCGAgonist trigger Buserelin 0,5 mg and Pregnyl (hCG) |
| hCG | Active comparator | Drug: Progesterone and EstradiolhCG trigger Pregnyl (hCG) and Progesterone and Estradiol |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age between 20 and 40
- Normal menstrual cycles: 25-34 days
- Oligomenorrhea/amenorrhea or polycystic syndrome (defined according to the Rotterdam criteria 2004)
- BMI >18 and <35 kg/m2
Key exclusion criteria (4 listed)
- Patients with >14 follicles on day of trigger
- Previous hyperresponse with OHSS development
- Previous low response (less than 3 oocytes on a high dose of FSH stimulation)
- Endocrine disorders
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 |
|---|---|---|
| hCG | Drug | Agonist trigger |
| Progesterone and Estradiol | Drug | hCG |
Primary outcome
Ongoing pregnancy rate per patient
Time frame: 10th week of gestation.
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 17 Dec 2020.
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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 4 study testing hCG and Progesterone and Estradiol in people with Infertility, run by Peter Humaidan at 1 site in Denmark.
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 4 inclusion and 4 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 17 Dec 2020. 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 Denmark. 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 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?
Ongoing pregnancy rate per patient (time frame: 10th week of gestation.). 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 17 Dec 2020.