IVFNCT04278508
Serum Progesterone on the Day of Thawed Embryo Transfer and Pregnancy Rate After an Artificial Endometrial Preparation
A study testing Progesterone in people with IVF, run by Hillel Yaffe Medical Center at 1 site in Israel.
Trial summary
To determine if different serum Progesterone levels on FET day are associated with different clinical pregnancy rates (CPR), and if increasing dosage of vaginal Progesterone in cases of lower serum Progesterone level on FET day can be either beneficial or detrimental regarding the CPR. Read more about this study
- Who is it for?
- Ages 18 to 38 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- IVF
- What is being tested?
- Progesterone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteIsrael
- Study dates
- 9 Mar 2020to 6 Jun 2022
- Phase
- Interventional
- 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 38 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- women between age 18-38 undergoing FET in AC
- with body mass index (BMI) < 35 kg/m2
- a triple layer endometrium >6.5 mm after exogenous estrogen administration
- 1-2 good quality day 3 or 5 FET.
Who cannot join
- women with recurrent pregnancy losses (e.g. 2 abortions beyond 12th week or 3 abortions before 12th week)
- recurrent implantation failure (e.g. unsuccessful implantation of ≥4 good quality embryos)
- severe male factor (sperm concentration <5 million/ml), or presence of hydrosalpinx.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Is There an Association Between Low Serum Progesterone on the Day of Frozen-thawed Embryo Transfer and a Reduced Clinical Pregnancy Rate After an Artificial Endometrial Preparation: A Randomized Control Trial
To determine if different serum Progesterone levels on FET day are associated with different clinical pregnancy rates (CPR), and if increasing dosage of vaginal Progesterone in cases of lower serum Progesterone level on FET day can be either beneficial or detrimental regarding the CPR.
Read the detailed description
Over the past decade, the use of frozen-thawed embryo transfer (FET) has risen around the globe. There is no consensus which mode of FET is superior, either natural cycle (NC) or artificial cycle (AC) with hormonal replacement therapy (HRT). The latter has become more and more popular because it allows more flexibility in timing of FET and it requires fewer visits for monitoring before the transfer. AC also has the advantage of a more precise control of progesterone (P) exposure, which is of utmost importance for controlling the window of implantation between the embryo and the endometrium. Although FET in AC give excellent results, there is still a need for improvement, as the ideal dose is not individualized to a patient's characteristics and serum P required for optimal cycle outcome haven't been established.
Retrospective studies about P levels on the day of FET in AC cycles showed contradictory results regarding cycle outcomes. Several studies showed that a lower P levels on FET day, or one day prior, are associated with lower clinical pregnancy rate (CPR) or live birth rate (LBR), whereas one study showed that women with higher P on FET day were having lower LBRs. Recently, a prospective study showed that serum P level < 9.2 ng/ml on the day of FET in oocyte reception cycles was associated with a significant lower ongoing pregnancy rate. Considering these previous studies, we wanted to determine if different serum P levels on FET day are associated with different CPR, and if increasing dosage of vaginal P in cases of lower serum P level on FET day can be either beneficial or detrimental.
- Conditions
- IVF
- Being tested
- Progesterone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProgesteroneDrug
To determine if different serum P levels on FET day are associated with different clinical pregnancy rates (CPR)
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | P < 10.0 ng/ml with increasing P dosage from 800 mg to 1200 mg daily from the FET day. Receives: Drug: Progesterone |
| Group B | Active comparator | P < 10.0 ng/ml without change in drug regimen. Receives: Drug: Progesterone |
| Group C | Active comparator | P ≥ 10.0 ng/ml without change in drug regimen. Receives: Drug: Progesterone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical pregnancy rate
Clinical pregnancy rate according to the presence of pregnancy sac on week 6-7 US.
Measured: 1 Year per patient
Secondary outcomes (1)
Laboratory end other long term outcomes
chemical pregnancy rate, miscarriage rate, and live birth rates.
Measured: 1 Year per patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2020
- Study start9 Mar 2020
- Primary completion6 Jun 2022
- Study completion6 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IVFStudies 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hillel Yaffe Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Einat Shalom-Paz, Prof., Principal investigator, Hillel Yaffe Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04278508
- Sponsor's protocol ID
- 0155-19-HYMC
- Status last verified
- Jun 2022
- First submitted
- 18 Feb 2020
- Last updated
- 23 Jun 2022
- 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 23 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is There an Association Between Low Serum Progesterone on the Day of Frozen-thawed Embryo Transfer and a Reduced Clinical Pregnancy Rate After an Artificial Endometrial Preparation: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT04278508
- Acronym / sponsor ID
- 0155-19-HYMC
- Conditions
- IVF
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Hillel Yaffe Medical CenterOther government
- Study start
- 9 Mar 2020 (actual)
- Primary completion
- 6 Jun 2022 (actual)
- Study completion
- 6 Jun 2022 (actual)
- First posted
- 20 Feb 2020 (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.
To determine if different serum Progesterone levels on FET day are associated with different clinical pregnancy rates (CPR), and if increasing dosage of vaginal Progesterone in cases of lower serum Progesterone level on FET day can be either beneficial or detrimental regarding the CPR.
Detailed description
Over the past decade, the use of frozen-thawed embryo transfer (FET) has risen around the globe. There is no consensus which mode of FET is superior, either natural cycle (NC) or artificial cycle (AC) with hormonal replacement therapy (HRT). The latter has become more and more popular because it allows more flexibility in timing of FET and it requires fewer visits for monitoring before the transfer. AC also has the advantage of a more precise control of progesterone (P) exposure, which is of utmost importance for controlling the window of implantation between the embryo and the endometrium. Although FET in AC give excellent results, there is still a need for improvement, as the ideal dose is not individualized to a patient's characteristics and serum P required for optimal cycle outcome haven't been established.
Retrospective studies about P levels on the day of FET in AC cycles showed contradictory results regarding cycle outcomes. Several studies showed that a lower P levels on FET day, or one day prior, are associated with lower clinical pregnancy rate (CPR) or live birth rate (LBR), whereas one study showed that women with higher P on FET day were having lower LBRs. Recently, a prospective study showed that serum P level < 9.2 ng/ml on the day of FET in oocyte reception cycles was associated with a significant lower ongoing pregnancy rate. Considering these previous studies, we wanted to determine if different serum P levels on FET day are associated with different CPR, and if increasing dosage of vaginal P in cases of lower serum P level on FET day can be either beneficial or detrimental.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Drug: ProgesteroneP < 10.0 ng/ml with increasing P dosage from 800 mg to 1200 mg daily from the FET day. |
| Group B | Active comparator | Drug: ProgesteroneP < 10.0 ng/ml without change in drug regimen. |
| Group C | Active comparator | Drug: ProgesteroneP ≥ 10.0 ng/ml without change in drug regimen. |
Who may qualify
- Ages
- 18 to 38 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- women between age 18-38 undergoing FET in AC
- with body mass index (BMI) < 35 kg/m2
- a triple layer endometrium >6.5 mm after exogenous estrogen administration
- 1-2 good quality day 3 or 5 FET.
Key exclusion criteria (3 listed)
- women with recurrent pregnancy losses (e.g. 2 abortions beyond 12th week or 3 abortions before 12th week)
- recurrent implantation failure (e.g. unsuccessful implantation of ≥4 good quality embryos)
- severe male factor (sperm concentration <5 million/ml), or presence of hydrosalpinx.
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 |
|---|---|---|
| ProgesteroneTo determine if different serum P levels on FET day are associated with different clinical pregnancy rates (CPR) | Drug | Group A, Group B, Group C |
Primary outcome
Clinical pregnancy rate
Time frame: 1 Year per patient
Clinical pregnancy rate according to the presence of pregnancy sac on week 6-7 US.
1 secondary outcome
Laboratory end other long term outcomes
Time frame: 1 Year per patient
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 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.
Einat Shalom-Paz, Prof. principal investigator
Hillel Yaffe Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Progesterone in people with IVF, run by Hillel Yaffe Medical Center at 1 site in Israel.
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 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 23 Jun 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 Israel. 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.
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: 1 Year per patient). 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 2022.