Biochemical Pregnancy Loss. A Multicenter Retrospective Study (BPL)

September 21, 2020 updated by: IVI Vigo

Is Biochemical Pregnancy Loss Associated to Embryo or Endometrium? A Multicenter Retrospective Study

Biochemical pregnancy loss (BPL) is a very frequent issue in human reproduction. After the implantation of the embryo, hCG disappears very soon from the maternal bloodstream and no evidence of a clinical pregnancy is seen. Different studies showed that factors such as age, oocyte and embryo quality, and endometrium receptivity may have something to do with the occurrence of biochemical pregnancy loss post assisted reproduction treatment.

The main aim of this study is to evaluate the incidence of biochemical pregnancy loss (BPL) in three different cohort populations; patients undergoing frozen embryo transfer (FET) from own oocytes after preimplantation genetic testing for aneuploidy (PGT-A), patients undergoing FET from own and donated oocytes and with endometrial receptivity array (ERA), and patients undergoing FET from own or donated oocytes (without PGTA or ERA test).

We will analyse the incidence of BPL in these populations and try to determine the role of the euploid status embryo in the first group, the endometrium in the second group and the third one as control group. We are waiting to find the value of both players in the origin of BPL.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Human embryo implantation is a poorly understood process. Once the embryo implants in the endometrium, it starts to secrete hCG that can be measured in the maternal blood as early as 9 days after implantation. Only a minimal number of pregnancies get to newborn, and the majority are lost before reach the first trimester (Larsen et al., 2013).

We are looking for the role of the embryo after controlling its chromosomal ploidy, and the endometrium after controlling its transcriptomic expression. We will also use a no exposed group to the controlled euploid embryo factor neither endometrial factor that is the oocyte donation group. This analysis expects to provide more information about the key role of embryo or endometrium in BPL.

Study Type

Observational

Enrollment (Actual)

20000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Pontevedra
      • Vigo, Pontevedra, Spain, 36203
        • IVI Vigo

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

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Infertile patients who come to participating centres for assisted reproduction treatments. Patients will be divided into 4 groups according to the treatment carried out: PGT-A, ERA, FET from own oocytes (CO) or FET from donated oocytes (CD).

Description

Inclusion Criteria:

Patients with the following selection criteria:

  • IVF/ICSI patients aged between 18 and 44
  • BMI 18-30 kg/m2
  • Frozen embryo transfer from own oocytes after PGT-A
  • Frozen embryo transfer with ERA test (from own or donated oocytes)
  • Frozen embryo transfer (from own or donated oocytes)
  • Single embryo transfer (SET) in all cycles
  • Patients without uterine malformations
  • Patients without recurrent miscarriage (≥ 3)
  • Patients with adequate endometrial thickness (> 7mm)
  • Patients without thyroid autoimmunity
  • Patients without thrombophilia
  • Exclude cycles with exclusively PGT-M
  • Exclude FET in ovarian stimulated cycles

Exclusion Criteria:

Exclude cycles with exclusively PGT-M Exclude FET in ovarian stimulated cycles

-

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

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
preimplantation genetic testing for aneuploidy (PGT-A) Group
Patients who have undergone preimplantation genetic testing for aneuploidy (PGT-A) (transfer of own frozen embryo)
Other: collect retrospectively data
Analyse the incidence of BPL in these populations
endometrial receptivity array (ERA) Group
Patients who have undergone frozen embryo transfer (FET) with endometrial receptivity array (ERA) test (embryos from own or donated oocytes)
Other: collect retrospectively data
Analyse the incidence of BPL in these populations
CONTROL OWN (CO) Group
Control group of FET from own oocytes (without ERA or PGT-A)
Other: collect retrospectively data
Analyse the incidence of BPL in these populations
CONTROL DONATED(CD) Group
Control group of FET from donated oocytes (without ERA or PGT-A)
Other: collect retrospectively data
Analyse the incidence of BPL in these populations

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Biochemical pregnancy loss (BPL)
Time Frame: Since 2013 to april 2019
when the maternal serum levels of β-hCG are higher than 10 UI/L, but in the transvaginal ultrasound is not possible to appreciate any gestational structure (dichotomous qualitative variable: yes/no). This variable is considered as the fraction between patients whose β-hCG is higher than 10 UI/L, without clinically recognized pregnancy, by number of pregnant patients.
Since 2013 to april 2019

Collaborators and Investigators

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

Sponsor

IVI Vigo

Collaborators

Instituto Valenciano de Infertilidad, IVI VALENCIA
IVI Madrid
Fundación IVI

Investigators

  • Principal Investigator: Elkin DR Muñoz, MD, IVI Vigo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

February 12, 2019

Primary Completion (Actual)

January 15, 2020

Study Completion (Actual)

January 15, 2020

Study Registration Dates

First Submitted

September 9, 2020

First Submitted That Met QC Criteria

September 14, 2020

First Posted (Actual)

September 16, 2020

Study Record Updates

Last Update Posted (Actual)

September 23, 2020

Last Update Submitted That Met QC Criteria

September 21, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1902-VGO-019-EM

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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