Pregnancy LossPhase 4NCT01943812
Substituted Frozen Embryo Transfer Cycles With GnRH-agonist Supplementation
A Phase 4 study testing Estradiol and progeterone in people with Pregnancy Loss and Frozen Embryo Transfer, run by Peter Humaidan at 2 sites in Denmark.
Trial summary
The aim of this study is to compare two FET protocols by modifying the substituted FET cycle in order to maintain a higher ongoing positive pregnancy rate and thus reduce the early pregnancy loss. Hypothesis: adding GnRH-agonist to the substituted cycle in FET treatment reduces the early pregnancy loss. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Loss, Frozen Embryo Transfer
- What is being tested?
- Estradiol and progeterone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 287 participants
- Where
- 2 sitesDenmark
- Study dates
- Dec 2013to Apr 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 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Endometrial thickness ≥ 7 mm after stimulation
- 18-45 years
- IVF/ICSI fertilisation
- BMI > 18,5 <30 kg/m2
- cycle length 25-34 days
Who cannot join
- endometrial thickness < 7 mm or no triple layer endometrium and/or functional follicles
- Uterine abnormality
- Chronic medical disease
- oocyte donation cycles
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
IVF syd
Fredericia, 7000
Fertility Clinic Regional Hospital Skive
Skive, 7800
About this study
The aim of this study is to compare two FET protocols by modifying the substituted FET cycle in order to maintain a higher ongoing positive pregnancy rate and thus reduce the early pregnancy loss.
Hypothesis: adding GnRH-agonist to the substituted cycle in FET treatment reduces the early pregnancy loss.
- Conditions
- Pregnancy Loss, Frozen Embryo Transfer
- Being tested
- Estradiol and progeterone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Estradiol and progeteroneDrug
Also called Estradiol and progesterone
Estradiol and progesterone
| Study group | Role | What they receive |
|---|---|---|
| Substituted FET cycle and GnRHa | Experimental | Substituted FET GnRH-a 2 bolus two days before Estradiol 6 mg Progesterone (Crinone) 180 mg Receives: Drug: Estradiol and progeterone |
| Substituted FET cycle | Active comparator | substituted FET cycle Estradiol Progesterone Receives: Drug: Estradiol and progeterone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pregnancy loss rate
Measured: Primary outcome is avaible after 12th week of gestational.
Secondary outcomes (1)
Pregnancy rate
Measured: 14 days after embryo transfer.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2013 (estimated)
- Study startDec 2013
- Primary completionApr 2019
- Study completionApr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy LossStudies 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
- 287 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peter Humaidan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Peter Humaidan, Regionshospitalet Viborg, Skive
- Investigators
- Birgit Alsbjerg, M.D., Principal investigator, Fertility Clinic Regional Hospital Skive
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01943812
- Sponsor's protocol ID
- Skive-2013-BA
- Status last verified
- Jun 2020
- First submitted
- 12 Sep 2013
- Last updated
- 23 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Substituted Frozen Embryo Transfer Cycles With GnRH-agonist Supplementation
- ClinicalTrials.gov ID
- NCT01943812
- Acronym / sponsor ID
- Skive-2013-BA
- Conditions
- Pregnancy Loss, Frozen Embryo Transfer
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 287 participants (actual)
- Lead sponsor
- Peter HumaidanUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Apr 2019 (actual)
- Study completion
- Apr 2020 (actual)
- First posted
- 17 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.
The aim of this study is to compare two FET protocols by modifying the substituted FET cycle in order to maintain a higher ongoing positive pregnancy rate and thus reduce the early pregnancy loss.
Hypothesis: adding GnRH-agonist to the substituted cycle in FET treatment reduces the early pregnancy loss.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Substituted FET cycle and GnRHa | Experimental | Drug: Estradiol and progeteroneSubstituted FET GnRH-a 2 bolus two days before Estradiol 6 mg Progesterone (Crinone) 180 mg |
| Substituted FET cycle | Active comparator | Drug: Estradiol and progeteronesubstituted FET cycle Estradiol Progesterone |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Endometrial thickness ≥ 7 mm after stimulation
- 18-45 years
- IVF/ICSI fertilisation
- BMI > 18,5 <30 kg/m2
- cycle length 25-34 days
Key exclusion criteria (4 listed)
- endometrial thickness < 7 mm or no triple layer endometrium and/or functional follicles
- Uterine abnormality
- Chronic medical disease
- oocyte donation cycles
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 |
|---|---|---|
| Estradiol and progeteroneAlso: Estradiol and progesteroneEstradiol and progesterone | Drug | Substituted FET cycle, Substituted FET cycle and GnRHa |
Primary outcome
Pregnancy loss rate
Time frame: Primary outcome is avaible after 12th week of gestational.
1 secondary outcome
Pregnancy rate
Time frame: 14 days after embryo transfer.
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 23 Jun 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.
Birgit Alsbjerg, M.D. principal investigator
Fertility Clinic Regional Hospital Skive
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Estradiol and progeterone in people with Pregnancy Loss and Frozen Embryo Transfer, run by Peter Humaidan at 2 sites 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 5 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 23 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Pregnancy loss rate (time frame: Primary outcome is avaible after 12th week of gestational.). 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 23 Jun 2020.