Impact of Corpus Luteum Presence or Absence in the Incidence of Preeclampsia After Frozen Embryo Transfer (PREECLAM-2019)

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

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

Study Locations

      • Valencia, Spain, 46015
        • Ivi Valencia

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.
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of pre-eclampsia during pregnancy.
Time Frame: 12 months
Presence or absence of pre-eclampsia during pregnancy
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bleeding during pregnancy
Time Frame: 12 months
Presence or absence of Bleeding during pregnancy
12 months
Hypertension during pregnancy
Time Frame: 12 months
Presence or absence of Hypertension during pregnancy
12 months
Eclampsia during pregnancy
Time Frame: 12 months
Presence or absence of Eclampsia during pregnancy
12 months
Preeclampsia during pregnancy
Time Frame: 12 months
Presence or absence of Preeclampsia during pregnancy
12 months
Retarded intrauterine growth during pregnancy
Time Frame: 12 months
Presence or absence of retarded intrauterine growth at birth
12 months
Premature detachment of normoinserted placenta during pregnancy
Time Frame: 12 months
Presence or absence of premature detachment of normoinserted placenta during pregnancy
12 months
Type II Diabetes during pregnancy
Time Frame: 12 months
Presence or absence of Type II Diabetes during pregnancy
12 months
Help Sindrome during pregnancy
Time Frame: 12 months
Presence or absence of Help Sindrome during pregnancy
12 months
Alterations in the volume of the amniotic fluid during pregnancy
Time Frame: 12 months
Presence or absence of alterations in the volume of the amniotic fluid during pregnancy
12 months
Preterm premature rupture of membranes during pregnancy.
Time Frame: 12 months
Presence or absence of preterm premature rupture of membranes during pregnancy
12 months
Fetal death
Time Frame: 12 months
Presence or absence of fetal death at birth.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

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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