Biochemical Pregnancy Loss. A Multicenter Retrospective Study

NCT04549909 | Completed

• 1 other identifier: 1902-VGO-019-EM
• Study Type: observational
• Target: 20,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy Loss, Early

Keywords

pregnancy; abortion; bioquemical

Outcome Measures

Primary Outcomes (1)

• Biochemical pregnancy loss (BPL)

  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

Study Arms (4)

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

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

CONTROL OWN (CO) Group

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

Other: collect retrospectively data

CONTROL DONATED(CD) Group

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

Other: collect retrospectively data

Interventions

collect retrospectively data OTHER

Analyse the incidence of BPL in these populations

CONTROL DONATED(CD) Group; CONTROL OWN (CO) Group; endometrial receptivity array (ERA) Group; preimplantation genetic testing for aneuploidy (PGT-A) Group

Eligibility Criteria

• Age: 18 Years - 44 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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).

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• IVI Vigo: lead
• Instituto Valenciano de Infertilidad, IVI VALENCIA: collaborator
• IVI Madrid: collaborator
• Fundación IVI: collaborator

Study Sites (1)

IVI Vigo

Vigo, Pontevedra, 36203, Spain

Location

Related Publications (2)

• 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.

  PMID: 20619403 RESULT

• 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.

  PMID: 38775331 DERIVED

MeSH Terms

Conditions

Abortion, Spontaneous

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Elkin DR Muñoz, MD

  IVI Vigo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2020
• First Posted: September 16, 2020
• Study Start: February 12, 2019
• Primary Completion: January 15, 2020
• Study Completion: January 15, 2020
• Last Updated: September 23, 2020

Record last verified: 2020-09

Locations

ES (1)