- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04092829
Impact of Corpus Luteum Presence or Absence in the Incidence of Preeclampsia After Frozen Embryo Transfer (PREECLAM-2019)
March 21, 2024 updated by: Instituto Valenciano de Infertilidad, IVI VALENCIA
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 Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
591
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: JOSE BELLVER PRADAS, MDPhD
- Phone Number: +34963050900
- Email: jose.bellver@ivirma.com
Study Locations
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Valencia, Spain, 46015
- Ivi Valencia
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 44 years (Adult)
Accepts Healthy Volunteers
No
Description
Inclusion criteria
- All patients who, after IVF-PGT-A treatment with their own oocytes, present a euploid embryo for transfer.
- Transfer of a single euploid embryo
Exclusion criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: FROZEN EMBRYO TRANSFER IN NATURAL CYCLE
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.
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Active Comparator: FROZEN EMBRYO TRANSFER IN SUBSTITUTED CYCLE
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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of pre-eclampsia during pregnancy.
Time Frame: 12 months
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Presence or absence of pre-eclampsia during pregnancy
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12 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Bleeding during pregnancy
Time Frame: 12 months
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Presence or absence of Bleeding during pregnancy
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12 months
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Hypertension during pregnancy
Time Frame: 12 months
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Presence or absence of Hypertension during pregnancy
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12 months
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Eclampsia during pregnancy
Time Frame: 12 months
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Presence or absence of Eclampsia during pregnancy
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12 months
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Preeclampsia during pregnancy
Time Frame: 12 months
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Presence or absence of Preeclampsia during pregnancy
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12 months
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Retarded intrauterine growth during pregnancy
Time Frame: 12 months
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Presence or absence of retarded intrauterine growth at birth
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12 months
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Premature detachment of normoinserted placenta during pregnancy
Time Frame: 12 months
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Presence or absence of premature detachment of normoinserted placenta during pregnancy
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12 months
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Type II Diabetes during pregnancy
Time Frame: 12 months
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Presence or absence of Type II Diabetes during pregnancy
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12 months
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Help Sindrome during pregnancy
Time Frame: 12 months
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Presence or absence of Help Sindrome during pregnancy
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12 months
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Alterations in the volume of the amniotic fluid during pregnancy
Time Frame: 12 months
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Presence or absence of alterations in the volume of the amniotic fluid during pregnancy
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12 months
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Preterm premature rupture of membranes during pregnancy.
Time Frame: 12 months
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Presence or absence of preterm premature rupture of membranes during pregnancy
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12 months
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Fetal death
Time Frame: 12 months
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Presence or absence of fetal death at birth.
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12 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: JOSE BELLVER PRADAS, MDPhD, IVIRMA VALENCIA
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 16, 2019
Primary Completion (Actual)
December 31, 2022
Study Completion (Actual)
December 31, 2022
Study Registration Dates
First Submitted
September 13, 2019
First Submitted That Met QC Criteria
September 16, 2019
First Posted (Actual)
September 17, 2019
Study Record Updates
Last Update Posted (Actual)
March 22, 2024
Last Update Submitted That Met QC Criteria
March 21, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1906-VLC-067-JB
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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