Biochemical Pregnancy Loss. A Multicenter Retrospective Study

Pregnancy Loss, Early Clinical Trial

— BPL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04549909
• Other study ID #: 1902-VGO-019-EM
• Status: Completed
• Start date: February 12, 2019
• Est. completion date: January 15, 2020

Study information

• Verified date: September 2020
• Source: IVI Vigo
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20000
• Est. completion date: January 15, 2020
• Est. primary completion date: January 15, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 44 Years

Eligibility

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

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Related Conditions & MeSH terms

• Abortion, Spontaneous
• Fetal Death
• Pregnancy Loss, Early

Intervention

Other:
• collect retrospectively data
Analyse the incidence of BPL in these populations

Locations

Country	Name	City	State
Spain	IVI Vigo	Vigo	Pontevedra

Sponsors (4)

Lead Sponsor	Collaborator
IVI Vigo	Fundación IVI, Instituto Valenciano de Infertilidad, IVI VALENCIA, IVI Madrid

Country where clinical trial is conducted

Spain, 

References & Publications (1)

Díaz-Gimeno P, Horcajadas JA, Martínez-Conejero JA, Esteban FJ, Alamá P, Pellicer A, Simón 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Biochemical pregnancy loss (BPL)	when the maternal serum levels of ß-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 ß-hCG is higher than 10 UI/L, without clinically recognized pregnancy, by number of pregnant patients.	Since 2013 to april 2019