Biochemical Pregnancy Loss. 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pregnancy Loss, Early Abortion, Spontaneous Female Urogenital Diseases and Pregnancy Complications Pregnancy Complications Urogenital Diseases

Age range

18 year–44 year

Sex eligibility

Female

Study type

Observational

Primary location

IVI Vigo

Vigo, Pontevedra, 36203, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Collect retrospectively data

Other

Analyse the incidence of BPL in these populations

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

IVI Vigo

Other

Collaborators

Fundación IVI
IVI Madrid
Instituto Valenciano de Infertilidad, IVI VALENCIA

Registry information

Official study title

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

Acronym: BPL

Important dates

Study start: 2019
Primary completion: 2020
Study completion: 2020
First posted: Sep 16, 2020
Registry last updated: Sep 23, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed