Pre-EclampsiaPREECLAM-2019NCT04092829
Impact of Corpus Luteum Presence or Absence in the Incidence of Preeclampsia After Frozen Embryo Transfer
A study testing FROZEN EMBRYO TRANSFER IN SUBSTITUTED CYCLE in people with Pre-Eclampsia and Frozen Embryo Transfer, run by Instituto Valenciano de Infertilidad, IVI VALENCIA at 1 site in Spain.
Trial summary
Identifying modifiable factors that contribute to preeclampsia risk associated with assisted reproduction can improve maternal health. Recent studies have shown an increased risk for hypertensive disorders of pregnancy after in vitro fertilization, particularly for pregnancies occurring during a hormone replacement… Read more about this study
- Who is it for?
- Ages 18 to 44 years, women only
- Conditions the study is for
- Pre-Eclampsia, Frozen Embryo Transfer
- What is being tested?
- FROZEN EMBRYO TRANSFER IN SUBSTITUTED CYCLE
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 591 participants
- Where
- 1 siteSpain
- Study dates
- 16 Sep 2019to 31 Dec 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 44 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- All patients who, after IVF-PGT-A treatment with their own oocytes, present a euploid embryo for transfer.
- Transfer of a single euploid embryo
Who cannot join
- Moderate or high smoking (> 5 cigarettes/day)
- BMI ≥30 kg/m2
- Chronic hypertension
- History of preeclampsia in previous pregnancies
- History of delayed uterine growth and placental insufficiency in previous pregnancies
- Use of donor sperm
- Woman's age ≥44 years
- Women with menstrual cycles longer than 35 days
Trial locations and contacts
1 site in 1 country.
About this study
Identifying modifiable factors that contribute to preeclampsia risk associated with assisted reproduction can improve maternal health. Recent studies have shown an increased risk for hypertensive disorders of pregnancy after in vitro fertilization, particularly for pregnancies occurring during a hormone replacement therapy such a donor egg recipient and a frozen embryo transfer. This risk may be partly attributable to the degree by which the assisted reproductive treatment affects the maternal hormonal environment, when the corpus luteum is a major source of reproductive hormones. On the other hand, cryopreserved embryos are usually thawed and replaced in in a natural or hormonally manipulated cycle; on this point, frozen embryo transfer is associated with better perinatal outcome regarding preterm birth and low birth weight yet higher risk of large for gestational age and macrosomia compared to fresh transfer. The objective of our study is to investigate whether the absence of corpus luteum adversely affects pregnancy and to analyse if there are differences in the perinatal outcomes due to differences in the endometrial preparation protocol for a frozen embryo transfer.
- Conditions
- Pre-Eclampsia, Frozen Embryo Transfer
- Being tested
- FROZEN EMBRYO TRANSFER IN SUBSTITUTED CYCLE
- Keywords
- Pre-Eclampsia, Corpus Luteum, Frozen embryo transfer, Endometrial preparation
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FROZEN EMBRYO TRANSFER IN SUBSTITUTED CYCLEProcedure or surgery
The intervention group will be prepared with hormone replacement therapy with estrogens according to usual clinical practice. Frozen embryos will be transferred after ten doses of exogenous progesterone.
| Study group | Role | What they receive |
|---|---|---|
| FROZEN EMBRYO TRANSFER IN NATURAL CYCLE | No intervention | After confirming ovarian rest (follicles < 10 mm) with menstruation by means of vaginal ultrasound, an ultrasound control of the natural cycle will be carried out, inducing ovulation when an ovulatory follicle of size ≥ 17mm and an endometrium ≥ 7mm are found. Serum estradiol and progesterone values will be determined that day. This induction will be carried out with an ampoule of 250 μg of rHCG (Ovitrelle®). After the injection of Ovitrelle®, the administration of micronized vaginal progesterone (Progeffik® or Utrogestan®) 200 mg/ 12 hours and 7 days after the injection, thawing and transfer of a frozen euploid blastocyst will begin 48 hours later. |
| FROZEN EMBRYO TRANSFER IN SUBSTITUTED CYCLE | Active comparator | After confirming ovarian rest (follicles < 10 mm) with menstruation by vaginal ultrasound, hormone replacement therapy with oestrogens (6 mg/day of oral oestradiol valerate - Progynova® or Progyluton®- or 150 ug/48 h of oestradiol in patches - Evopad®) will be started on day 2-3 of the cycle. On day 10-15 of treatment an ultrasound scan will be performed to assess endometrial growth and ovarian rest. After confirming an endometrial thickness ≥ 7mm by vaginal ultrasound, ovaries with follicles smaller than 10 mm, blood estradiol >100 pg/ml and serum progesterone < 1 ng/ml, luteal phase support will begin with the administration of 400 mg of micronized vaginal progesterone every 12 hours, a total of 10 shots, prior to embryo transfer of a thawed euploid blastocyst. same day. If the level of serum progesterone on the day of transfer is less than 9.2 ng/ml, a daily injection of subcutaneous progesterone (Prolutex®) will be added on the same day. Receives: Procedure: FROZEN EMBRYO TRANSFER IN SUBSTITUTED CYCLE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of pre-eclampsia during pregnancy.
Presence or absence of pre-eclampsia during pregnancy
Measured: 12 months
Secondary outcomes (11)
Bleeding during pregnancy
Presence or absence of Bleeding during pregnancy
Measured: 12 months
Hypertension during pregnancy
Presence or absence of Hypertension during pregnancy
Measured: 12 months
Eclampsia during pregnancy
Presence or absence of Eclampsia during pregnancy
Measured: 12 months
Preeclampsia during pregnancy
Presence or absence of Preeclampsia during pregnancy
Measured: 12 months
Retarded intrauterine growth during pregnancy
Presence or absence of retarded intrauterine growth at birth
Measured: 12 months
Premature detachment of normoinserted placenta during pregnancy
Presence or absence of premature detachment of normoinserted placenta during pregnancy
Measured: 12 months
Type II Diabetes during pregnancy
Presence or absence of Type II Diabetes during pregnancy
Measured: 12 months
Help Sindrome during pregnancy
Presence or absence of Help Sindrome during pregnancy
Measured: 12 months
Alterations in the volume of the amniotic fluid during pregnancy
Presence or absence of alterations in the volume of the amniotic fluid during pregnancy
Measured: 12 months
Preterm premature rupture of membranes during pregnancy.
Presence or absence of preterm premature rupture of membranes during pregnancy
Measured: 12 months
Fetal death
Presence or absence of fetal death at birth.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2019
- Study start16 Sep 2019
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Why it stopped: under-recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pre-EclampsiaStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized prospective analysis.
- Masking
- None (open label)
- Enrolment
- 591 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Valenciano de Infertilidad, IVI VALENCIA
- Sponsor type
- University, hospital or other
- Collaborators
- IVI Bilbao, IVI Barcelona, IVI Madrid, Vida Recoletas Sevilla, IVI Vigo, IVI Roma, Hospital Universitario La Paz, IVI Mallorca
- Responsible party
- Sponsor
- Investigators
- JOSE BELLVER PRADAS, MDPhD, Principal investigator, IVIRMA VALENCIA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04092829
- Sponsor's protocol ID
- 1906-VLC-067-JB
- Acronym
- PREECLAM-2019
- Status last verified
- Mar 2024
- First submitted
- 13 Sep 2019
- Last updated
- 22 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 22 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Corpus Luteum Presence or Absence in the Incidence of Preeclampsia After Frozen Embryo Transfer
- ClinicalTrials.gov ID
- NCT04092829
- Acronym / sponsor ID
- PREECLAM-2019 / 1906-VLC-067-JB
- Conditions
- Pre-Eclampsia, Frozen Embryo Transfer
- Keywords
- Pre-Eclampsia, Corpus Luteum, Frozen embryo transfer, Endometrial preparation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: under-recruitment
- Enrolment
- 591 participants (actual)
- Lead sponsor
- Instituto Valenciano de Infertilidad, IVI VALENCIAUniversity, hospital or other
- Collaborators
- IVI Bilbao, IVI Barcelona, IVI Madrid, Vida Recoletas Sevilla, IVI Vigo, IVI Roma, Hospital Universitario La Paz, IVI Mallorca
- Study start
- 16 Sep 2019 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 17 Sep 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.
Identifying modifiable factors that contribute to preeclampsia risk associated with assisted reproduction can improve maternal health. Recent studies have shown an increased risk for hypertensive disorders of pregnancy after in vitro fertilization, particularly for pregnancies occurring during a hormone replacement therapy such a donor egg recipient and a frozen embryo transfer. This risk may be partly attributable to the degree by which the assisted reproductive treatment affects the maternal hormonal environment, when the corpus luteum is a major source of reproductive hormones. On the other hand, cryopreserved embryos are usually thawed and replaced in in a natural or hormonally manipulated cycle; on this point, frozen embryo transfer is associated with better perinatal outcome regarding preterm birth and low birth weight yet higher risk of large for gestational age and macrosomia compared to fresh transfer. The objective of our study is to investigate whether the absence of corpus luteum adversely affects pregnancy and to analyse if there are differences in the perinatal outcomes due to differences in the endometrial preparation protocol for a frozen embryo transfer.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized prospective analysis.
| Arm | Type | Receives |
|---|---|---|
| FROZEN EMBRYO TRANSFER IN NATURAL CYCLE | No intervention | –After confirming ovarian rest (follicles < 10 mm) with menstruation by means of vaginal ultrasound, an ultrasound control of the natural cycle will be carried out, inducing ovulation when an ovulatory follicle of size ≥ 17mm and an endometrium ≥ 7mm are found. Serum estradiol and progesterone values will be determined that day. This induction will be carried out with an ampoule of 250 μg of rHCG (Ovitrelle®). After the injection of Ovitrelle®, the administration of micronized vaginal progesterone (Progeffik® or Utrogestan®) 200 mg/ 12 hours and 7 days after the injection, thawing and transfer of a frozen euploid blastocyst will begin 48 hours later. |
| FROZEN EMBRYO TRANSFER IN SUBSTITUTED CYCLE | Active comparator | Procedure: FROZEN EMBRYO TRANSFER IN SUBSTITUTED CYCLEAfter confirming ovarian rest (follicles < 10 mm) with menstruation by vaginal ultrasound, hormone replacement therapy with oestrogens (6 mg/day of oral oestradiol valerate - Progynova® or Progyluton®- or 150 ug/48 h of oestradiol in patches - Evopad®) will be started on day 2-3 of the cycle. On day 10-15 of treatment an ultrasound scan will be performed to assess endometrial growth and ovarian rest. After confirming an endometrial thickness ≥ 7mm by vaginal ultrasound, ovaries with follicles smaller than 10 mm, blood estradiol >100 pg/ml and serum progesterone < 1 ng/ml, luteal phase support will begin with the administration of 400 mg of micronized vaginal progesterone every 12 hours, a total of 10 shots, prior to embryo transfer of a thawed euploid blastocyst. same day. If the level of serum progesterone on the day of transfer is less than 9.2 ng/ml, a daily injection of subcutaneous progesterone (Prolutex®) will be added on the same day. |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- All patients who, after IVF-PGT-A treatment with their own oocytes, present a euploid embryo for transfer.
- Transfer of a single euploid embryo
Key exclusion criteria (8 listed)
- Moderate or high smoking (> 5 cigarettes/day)
- BMI ≥30 kg/m2
- Chronic hypertension
- History of preeclampsia in previous pregnancies
- History of delayed uterine growth and placental insufficiency in previous pregnancies
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 |
|---|---|---|
| FROZEN EMBRYO TRANSFER IN SUBSTITUTED CYCLEThe intervention group will be prepared with hormone replacement therapy with estrogens according to usual clinical practice. Frozen embryos will be transferred after ten doses of exogenous progesterone. | Procedure or surgery | FROZEN EMBRYO TRANSFER IN SUBSTITUTED CYCLE |
Primary outcome
Incidence of pre-eclampsia during pregnancy.
Time frame: 12 months
Presence or absence of pre-eclampsia during pregnancy
11 secondary outcomes
Bleeding during pregnancy
Time frame: 12 months
Hypertension during pregnancy
Time frame: 12 months
Eclampsia during pregnancy
Time frame: 12 months
Preeclampsia during pregnancy
Time frame: 12 months
Retarded intrauterine growth during pregnancy
Time frame: 12 months
Premature detachment of normoinserted placenta during pregnancy
Time frame: 12 months
Type II Diabetes during pregnancy
Time frame: 12 months
Help Sindrome during pregnancy
Time frame: 12 months
Alterations in the volume of the amniotic fluid during pregnancy
Time frame: 12 months
Preterm premature rupture of membranes during pregnancy.
Time frame: 12 months
Fetal death
Time frame: 12 months
Results and safety
The study was stopped early (reason given: under-recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2024.
- Individual participant dataSharing planned: Undecided
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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.
JOSE BELLVER PRADAS, MDPhD principal investigator
IVIRMA VALENCIA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FROZEN EMBRYO TRANSFER IN SUBSTITUTED CYCLE in people with Pre-Eclampsia and Frozen Embryo Transfer, run by Instituto Valenciano de Infertilidad, IVI VALENCIA at 1 site in Spain.
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 2 inclusion and 8 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: stopped early, as of the sponsor's last update on 22 Mar 2024. 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 Spain. 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 was stopped early (reason given: under-recruitment). Results are not available in the source record.
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?
Incidence of pre-eclampsia during pregnancy. (time frame: 12 months). 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 22 Mar 2024.