Frozen Embryo TransferFETNCT04114500
The Association Between Serum E2 and P on the Day of FET and the Pregnancy Outcome
An observational study of Frozen Embryo Transfer, run by Al Baraka Fertility Hospital at 1 site in Bahrain.
Trial summary
The outcomes of frozen embryo transfer (FET) have substantially improved over the last decade, due to the improvements in the cryopreservation process, Artificial endometrial preparation is typically accomplished by the administration of estradiol (E2) supplementation and exogenous progesterone (P) in order to… Read more about this study
- Who is it for?
- Ages 22 to 40 years, women only
- Conditions the study is for
- Frozen Embryo Transfer
- What is being tested?
- serum estradiol and progesterone
- How many people
- 402 participants
- Where
- 1 siteBahrain
- Study dates
- 3 Apr 2018to 5 May 2019
- Phase
- Observational
- 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 22 to 40 years
- Women only
- Adult
Study population: Patients undergoing IVF/FET were recruited from April 2018 to September 2019.
Who may be able to join
- patients who underwent frozen-thawed embryos transfer treatment
- the endometrial preparation was initiated with oral estradiol valerate
- the endometrial thickness was no less than 8 mm on the day when P was administrated;
- normal endometrial ultrasound imaging
- euploid pre-genetically tested embryos
Who cannot join
- age> 40 years
- BMI > 35
- abnormal ultrasonogram of uterine cavity
- abnormal embryos not suitable for transfer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Association Between Serum Estradiol and Progesterone on the Same Day of FET and the Pregnancy Outcome
The outcomes of frozen embryo transfer (FET) have substantially improved over the last decade, due to the improvements in the cryopreservation process, Artificial endometrial preparation is typically accomplished by the administration of estradiol (E2) supplementation and exogenous progesterone (P) in order to transform the endometrium into a secretory one, mimicking a natural cycle , The current study aims to determine the association, if any, between serum E2 and P levels, measured same day of FET, and pregnancy outcome
Read the detailed description
Study design a retrospective cohort study for 402 FET cycles which will be conducted in Al- Baraka Fertility Hospital, Manama, Bahrain, between April 2018 and May 2019. The trial registration number for the study is (NCT04114500), and it was approved by our ethical committee Study population
- Inclusion criteria were women who underwent FET, were age below 40 yrs., body mass index (BMI) below 30 kg/m2, patients who underwent FET treatment using the endometrial preparation was initiated with oral estradiol valerate, the endometrial thickness was no less than 8 mm on the day when P was administrated; with normal endometrial ultrasound imaging and euploid pre-genetically tested embryos;
- Exclusion criteria were chromosomal and genetic disorders, age> 40 years, BMI > 35 , abnormal ultrasonogram of uterine cavity (acquired or congenital) and abnormal embryos not suitable for transfer.
Study protocol Endometrial preparation in frozen embryo transfer (FET) briefly, patients received treatment with 2 mg/8h E2 (Estrofem, Novo Nordisk) for 12-14 days, Endometrial thickness was evaluated with transvaginal sonography. When endometrial thickness reached 8 mm or greater and was trilaminar in appearance, patients were initiated on both vaginal micronized P (Crinone gel, Merck) and oral P (Duphastone, Abott) treatment at 200 mg/8h. P4 was given as supplementation because normal ovarian steroid production and the ovarian follicular-to-luteal transition were suppressed with estradiol. A depot GnRH agonist was administered in the midluteal phase of the preceding cycle at clinician's discretion. On the early morning of day 5 of P treatment, the same day of FET, a blood sample was obtained and immediately analyzed. Hormone determinations of E2 and P were performed. Then, embryo transfer of the pre-genetically tested euploid embryos was performed under ultrasound guidance. 12 days later pregnancy test was assessed, 4 weeks after FET date ultrasound will be scheduled to check the viability and clinical pregnancy.
- Conditions
- Frozen Embryo Transfer
- Being tested
- serum estradiol and progesterone
- Keywords
- Estradiol, FET, IVF, Progesterone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
serum estradiol and progesteroneDiagnostic test
blood sample for measuring serum estradiol and progesterone level on the same day of FET
What is being measured
The primary outcome is the main question the study is designed to answer.
Pregnancy rate
B-hCG
Measured: 2 weeks
clinical pregnancy rate
positive fetal heart beat
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2019
- Study start3 Apr 2018
- Primary completion1 May 2019
- Study completion5 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Frozen Embryo TransferStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 402 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al Baraka Fertility Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Kamal Rageh, Al Baraka Fertility Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04114500
- Sponsor's protocol ID
- KAMAL
- Acronym
- FET
- Status last verified
- Jul 2020
- First submitted
- 22 Sep 2019
- Last updated
- 8 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Association Between Serum Estradiol and Progesterone on the Same Day of FET and the Pregnancy Outcome
- ClinicalTrials.gov ID
- NCT04114500
- Acronym / sponsor ID
- FET / KAMAL
- Conditions
- Frozen Embryo Transfer
- Keywords
- Estradiol, FET, IVF, Progesterone
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 402 participants (actual)
- Lead sponsor
- Al Baraka Fertility HospitalUniversity, hospital or other
- Study start
- 3 Apr 2018 (actual)
- Primary completion
- 1 May 2019 (actual)
- Study completion
- 5 May 2019 (actual)
- First posted
- 3 Oct 2019 (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 outcomes of frozen embryo transfer (FET) have substantially improved over the last decade, due to the improvements in the cryopreservation process, Artificial endometrial preparation is typically accomplished by the administration of estradiol (E2) supplementation and exogenous progesterone (P) in order to transform the endometrium into a secretory one, mimicking a natural cycle , The current study aims to determine the association, if any, between serum E2 and P levels, measured same day of FET, and pregnancy outcome
Detailed description
Study design a retrospective cohort study for 402 FET cycles which will be conducted in Al- Baraka Fertility Hospital, Manama, Bahrain, between April 2018 and May 2019. The trial registration number for the study is (NCT04114500), and it was approved by our ethical committee Study population
- Inclusion criteria were women who underwent FET, were age below 40 yrs., body mass index (BMI) below 30 kg/m2, patients who underwent FET treatment using the endometrial preparation was initiated with oral estradiol valerate, the endometrial thickness was no less than 8 mm on the day when P was administrated; with normal endometrial ultrasound imaging and euploid pre-genetically tested embryos;
- Exclusion criteria were chromosomal and genetic disorders, age> 40 years, BMI > 35 , abnormal ultrasonogram of uterine cavity (acquired or congenital) and abnormal embryos not suitable for transfer.
Study protocol Endometrial preparation in frozen embryo transfer (FET) briefly, patients received treatment with 2 mg/8h E2 (Estrofem, Novo Nordisk) for 12-14 days, Endometrial thickness was evaluated with transvaginal sonography. When endometrial thickness reached 8 mm or greater and was trilaminar in appearance, patients were initiated on both vaginal micronized P (Crinone gel, Merck) and oral P (Duphastone, Abott) treatment at 200 mg/8h. P4 was given as supplementation because normal ovarian steroid production and the ovarian follicular-to-luteal transition were suppressed with estradiol. A depot GnRH agonist was administered in the midluteal phase of the preceding cycle at clinician's discretion. On the early morning of day 5 of P treatment, the same day of FET, a blood sample was obtained and immediately analyzed. Hormone determinations of E2 and P were performed. Then, embryo transfer of the pre-genetically tested euploid embryos was performed under ultrasound guidance. 12 days later pregnancy test was assessed, 4 weeks after FET date ultrasound will be scheduled to check the viability and clinical pregnancy.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 22 to 40 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- Patients undergoing IVF/FET were recruited from April 2018 to September 2019.
Key inclusion criteria (5 listed)
- patients who underwent frozen-thawed embryos transfer treatment
- the endometrial preparation was initiated with oral estradiol valerate
- the endometrial thickness was no less than 8 mm on the day when P was administrated;
- normal endometrial ultrasound imaging
- euploid pre-genetically tested embryos
Key exclusion criteria (4 listed)
- age> 40 years
- BMI > 35
- abnormal ultrasonogram of uterine cavity
- abnormal embryos not suitable for transfer
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 |
|---|---|---|
| serum estradiol and progesteroneblood sample for measuring serum estradiol and progesterone level on the same day of FET | Diagnostic test | – |
Primary outcome
Pregnancy rate
Time frame: 2 weeks
B-hCG
clinical pregnancy rate
Time frame: 4 weeks
positive fetal heart beat
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 8 Jul 2020.
- Individual participant dataSharing planned: Undecided
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Infertility (IVF Patients)
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?
An observational study of Frozen Embryo Transfer, run by Al Baraka Fertility Hospital at 1 site in Bahrain.
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 8 Jul 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 Bahrain. 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?
Pregnancy rate (time frame: 2 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 8 Jul 2020.