Biochemical Pregnancy Loss. A Multicenter Retrospective Study

NCT ID: NCT04549909

Last Updated: 2020-09-23

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 20000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-02-12
• Study Completion Date: 2020-01-15

Brief Summary

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.

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.

Conditions

Pregnancy Loss, Early

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

preimplantation genetic testing for aneuploidy (PGT-A) Group

Patients who have undergone preimplantation genetic testing for aneuploidy (PGT-A) (transfer of own frozen embryo)

collect retrospectively data

Intervention Type: OTHER

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)

collect retrospectively data

Intervention Type: OTHER

Analyse the incidence of BPL in these populations

CONTROL OWN (CO) Group

Control group of FET from own oocytes (without ERA or PGT-A)

collect retrospectively data

Intervention Type: OTHER

Analyse the incidence of BPL in these populations

CONTROL DONATED(CD) Group

Control group of FET from donated oocytes (without ERA or PGT-A)

collect retrospectively data

Intervention Type: OTHER

Analyse the incidence of BPL in these populations

Interventions

collect retrospectively data

Analyse the incidence of BPL in these populations

Intervention Type: OTHER

Eligibility Criteria

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

-

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 44 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Instituto Valenciano de Infertilidad, IVI VALENCIA

OTHER

Sponsor Role: collaborator

IVI Madrid

OTHER

Sponsor Role: collaborator

Fundación IVI

OTHER

Sponsor Role: collaborator

IVI Vigo

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Elkin DR Muñoz, MD

Role: PRINCIPAL_INVESTIGATOR

IVI Vigo

Locations

IVI Vigo

Vigo, Pontevedra, Spain

Countries

Spain

References

Diaz-Gimeno P, Horcajadas JA, Martinez-Conejero JA, Esteban FJ, Alama P, Pellicer A, Simon C. A genomic diagnostic tool for human endometrial receptivity based on the transcriptomic signature. Fertil Steril. 2011 Jan;95(1):50-60, 60.e1-15. doi: 10.1016/j.fertnstert.2010.04.063. Epub 2010 Jul 8.

Reference Type: RESULT

PMID: 20619403 (View on PubMed)

Munoz E, Taboas E, Alvarez M, Gil E, Perez A, Portela S, Martinez-Chapela M, Saucedo E, Garrido N. Is biochemical pregnancy loss associated with embryo or endometrium? A retrospective cohort study in frozen single embryo transfer of own and donated oocytes. Hum Reprod. 2024 May 22:deae106. doi: 10.1093/humrep/deae106. Online ahead of print.

Reference Type: DERIVED

PMID: 38775331 (View on PubMed)

Other Identifiers

1902-VGO-019-EM

Identifier Type: -

Identifier Source: org_study_id