Estradiol, Progesterone and Endometrial Thickness in Frozen Euploid Embryo Transfer

Infertility Clinical Trial

Official title:

Estradiol, Progesterone and Endometrial Thickness in Frozen Euploid Embryo Transfer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03395665
• Other study ID #: SMD-2018-01
• Status: Completed
• Phase: N/A
• First received: January 4, 2018
• Last updated: February 27, 2018
• Start date: January 2014
• Est. completion date: January 2018

Study information

• Verified date: February 2018
• Source: Institut Universitari Dexeus
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The development and improvement in Preimplantation genetic diagnosis/screening (PGS) in association with the efficacy and security of vitrification and trophectoderm biopsy, more efficient stimulation schemes and laboratory improvements in culture and embryo selection have contributed to high success of the assisted reproductive technologies(ART). Transferring an euploid embryo avoids one of the main reasons of miscarriage and implantation failure ( Rubio et al, 22016) and overcomes one of the most important confounding factors. Usually, the transfer of euploid embryos is performed under standard hormone replacement therapy (HRT) and are referred to as FET-PGS cycles( Frozen embryo transfer). The study of FET-PGS cycles with the transfer of a single euploid blastocyst is the best model for evaluation of the impact of the endometrial preparation . Among factors influencing FET outcomes, patient's age, endometrial preparation, endometrium thickness, endometrial pattern, number and quality of embryos transferred , difficulty at ET, recently P4 have received more attention .

The importance of Progesterone (P4) in embryo implantation has been widely studied. P4 plays an important role in endometrial gland formation, embryonic implantation and pregnancy maintenance, both in natural and artificial cycles.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 299
• Est. completion date: January 2018
• Est. primary completion date: December 2017
• Gender: Female
• Age group: 18 Years to 43 Years

Eligibility

Inclusion Criteria:

• Frozen embryo transfer (FET) of at least one single euploid embryo.

• Estradiol > 75pg/ml.

• Progesterone > 4 ng/ml.

• Endometrial thickness between 6 mm and 18 mm.

Exclusion Criteria:

• Patients with FET of no diagnostic or mosaic embryos, or known uterine abnormality were excluded.

• Natura cycle protocol.

Related Conditions & MeSH terms

• Abortion, Spontaneous
• Infertility
• Miscarriage
• Preimplantation Genetic Diagnosis/Screening

Intervention

Other:
• Estradiol level
Estradiol level measured at previous day of embryo transfer procedure
• Progesterone level
Progesterone level measured at previous day of embryo transfer procedure
• Endometrial thickness
Endometrial thickness measured at previous day of embryo transfer procedure

Locations

Country	Name	City	State
Spain	Department of Obstetrics, Gynaecology and Reproduction Instituto Universitario Dexeus	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Institut Universitari Dexeus

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Live birth rate		Ten months after transfer procedure
Primary	Miscarriage rate	Miscarriage was defined as a loss following a positive pregnancy test and/or detectable Gestational sac	Any pregnancy loss before week 20
Primary	Pregnancy rate		6 weeks after transfer procedure

External Links

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