InfertilityPhase 4ESTRO-FETNCT04997525
Estradiol and Progesterone Levels Following Frozen Embryo Transfer
A Phase 4 study testing Estradiol Tablets, Progesterone and Follitropin Alfa in people with Infertility, run by Copenhagen University Hospital at Herlev at 1 site in Denmark.
Trial summary
The aim of the present study is to investigate serum estradiol and progesterone levels in women conceiving after natural, estradiol + progesterone or gonadotropin stimulated frozen embryo transfer (FET) cycles. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility
- What is being tested?
- Estradiol Tablets, Progesterone and Follitropin Alfa
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 305 participants
- Where
- 1 siteDenmark
- Study dates
- 20 Apr 2021to 6 Dec 2024
- 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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age > 18 years < 40 years
- BMI < 35 kg/m2
- Normal wet smear within the past three years
- Thawed blastocysts (day 5 or 6) after either IVF or ICSI treatment
Who cannot join
- Age < 18 years
- BMI > 35 kg/m2
- Oocyte donation
- HIV/ hepatitis
- Undiagnosed vaginal bleeding
- Uterine malformations
Show all 17Show fewer
- Persisting ovarian cysts
- Tumors in Hypothalamus, pituitary, thyroid or adrenal
- Previous breast cancer
- BRCA1/2
- Unregulated thyroid disease
- Cardiovascular disease
- Breast feeding
- Present or previous chemotherapy/radiation therapy
- Present or previous malignant disease
- Smoking
- Alcohol/drug abuse
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Estradiol and Progesterone Levels in Early Pregnancy After Natural, Estradiol + Progesterone or Gonadotrophin Stimulated Frozen Embryo Transfer Cycle
The aim of the present study is to investigate serum estradiol and progesterone levels in women conceiving after natural, estradiol + progesterone or gonadotropin stimulated frozen embryo transfer (FET) cycles.
Read the detailed description
Enrolled women will be randomized based on their ovulation pattern. Ovulatory women will be randomized to either natural cycle or estradiol + progesterone substituted cycle treatment for FET. Anovulatory women will be randomized to either estradiol + progesterone substituted cycle or gonadotropin stimulated cycle treatment for FET.
Included women will undergo blood testing every two weeks for serum estradiol and progesterone levels until gestational age 9+6. Routine vaginal ultrasounds will be performed as well as additional pregnancy ultrasounds.
Secondary obstetric outcomes will be investigated using the womens medical journals.
All the treatments are considered standard treatments for FET.
- Conditions
- Infertility
- Being tested
- Estradiol Tablets, Progesterone, Follitropin Alfa, Chorionic Gonadotropin, Alpha
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Estradiol TabletsDrug
Combined with progesterone
ProgesteroneDrug
Combined with estradiol
Follitropin AlfaDrug
Combined with hCG
Chorionic Gonadotropin, AlphaDrug
In either natural cycle or combined with Follitropin Alfa
| Study group | Role | What they receive |
|---|---|---|
| Natural cycle | Active comparator | These women will follow their natural cycle and receive one injection of hCG for stimulation of ovulation before embryo transfer Receives: Drug: Chorionic Gonadotropin, Alpha |
| Estradiol and progesterone | Active comparator | These women will receive daily estradiol and progesterone tablets/capsules before and after embryo transfer. Treatment will continue until gestational age 9+6 Receives: Drug: Estradiol Tablets; Drug: Progesterone |
| Gonadotropin | Active comparator | These women will receive daily gonadotropin injection before embryo transfer. Ovulation will be stimulated using hCG injection. Receives: Drug: Follitropin Alfa; Drug: Chorionic Gonadotropin, Alpha |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum estradiol
Blood samples in the first 10 weeks of pregnancy
Measured: 10 weeks
Serum progesterone
Blood samples in the first 10 weeks of pregnancy
Measured: 10 weeks
Secondary outcomes (4)
Gestational age at delivery
Weeks of pregnancy when the child has been delivered
Measured: At delivery
Child birth weight
Weight of the child at delivery
Measured: At delivery
Obstetric complications
Obsteric complication throughout pregnancy
Measured: 9 months
Child malformations
Child malformations diagnosed in utero or at delivery
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2021
- Study start20 Apr 2021
- Primary completion7 May 2024
- Study completion6 Dec 2024
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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 305 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital at Herlev
- Sponsor type
- University, hospital or other
- Collaborators
- Copenhagen University Hospital, Hvidovre
- Responsible party
- Principal investigator, Pernille Fog Svendsen, DMSc, Copenhagen University Hospital at Herlev
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04997525
- Sponsor's protocol ID
- 2020-001218-39
- Acronym
- ESTRO-FET
- Status last verified
- Dec 2024
- First submitted
- 22 Jun 2021
- Last updated
- 3 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Estradiol and Progesterone Levels in Early Pregnancy After Natural, Estradiol + Progesterone or Gonadotrophin Stimulated Frozen Embryo Transfer Cycle
- ClinicalTrials.gov ID
- NCT04997525
- Acronym / sponsor ID
- ESTRO-FET / 2020-001218-39
- Conditions
- Infertility
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 305 participants (actual)
- Lead sponsor
- Copenhagen University Hospital at HerlevUniversity, hospital or other
- Collaborators
- Copenhagen University Hospital, Hvidovre
- Study start
- 20 Apr 2021 (actual)
- Primary completion
- 7 May 2024 (actual)
- Study completion
- 6 Dec 2024 (actual)
- First posted
- 9 Aug 2021 (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 aim of the present study is to investigate serum estradiol and progesterone levels in women conceiving after natural, estradiol + progesterone or gonadotropin stimulated frozen embryo transfer (FET) cycles.
Detailed description
Enrolled women will be randomized based on their ovulation pattern. Ovulatory women will be randomized to either natural cycle or estradiol + progesterone substituted cycle treatment for FET. Anovulatory women will be randomized to either estradiol + progesterone substituted cycle or gonadotropin stimulated cycle treatment for FET.
Included women will undergo blood testing every two weeks for serum estradiol and progesterone levels until gestational age 9+6. Routine vaginal ultrasounds will be performed as well as additional pregnancy ultrasounds.
Secondary obstetric outcomes will be investigated using the womens medical journals.
All the treatments are considered standard treatments for FET.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Natural cycle | Active comparator | Drug: Chorionic Gonadotropin, AlphaThese women will follow their natural cycle and receive one injection of hCG for stimulation of ovulation before embryo transfer |
| Estradiol and progesterone | Active comparator | Drug: Estradiol Tablets, Drug: ProgesteroneThese women will receive daily estradiol and progesterone tablets/capsules before and after embryo transfer. Treatment will continue until gestational age 9+6 |
| Gonadotropin | Active comparator | Drug: Follitropin Alfa, Drug: Chorionic Gonadotropin, AlphaThese women will receive daily gonadotropin injection before embryo transfer. Ovulation will be stimulated using hCG injection. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age > 18 years < 40 years
- BMI < 35 kg/m2
- Normal wet smear within the past three years
- Thawed blastocysts (day 5 or 6) after either IVF or ICSI treatment
Key exclusion criteria (17 listed)
- Age < 18 years
- BMI > 35 kg/m2
- Oocyte donation
- HIV/ hepatitis
- Undiagnosed vaginal bleeding
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 TabletsCombined with progesterone | Drug | Estradiol and progesterone |
| ProgesteroneCombined with estradiol | Drug | Estradiol and progesterone |
| Follitropin AlfaCombined with hCG | Drug | Gonadotropin |
| Chorionic Gonadotropin, AlphaIn either natural cycle or combined with Follitropin Alfa | Drug | Gonadotropin, Natural cycle |
Primary outcome
Serum estradiol
Time frame: 10 weeks
Blood samples in the first 10 weeks of pregnancy
Serum progesterone
Time frame: 10 weeks
Blood samples in the first 10 weeks of pregnancy
4 secondary outcomes
Gestational age at delivery
Time frame: At delivery
Child birth weight
Time frame: At delivery
Obstetric complications
Time frame: 9 months
Child malformations
Time frame: 9 months
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 3 Jan 2025.
- Individual participant dataSharing planned: No
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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 Estradiol Tablets, Progesterone and Follitropin Alfa in people with Infertility, run by Copenhagen University Hospital at Herlev 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 17 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 3 Jan 2025. 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?
Serum estradiol (time frame: 10 weeks). The study lists 2 primary outcomes in all. 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 3 Jan 2025.