Estradiol, Progesterone and Endometrial Thickness in Frozen Euploid Embryo Transfer

Completed

• Conditions: Infertility; Preimplantation Genetic Diagnosis/Screening; Miscarriage

• Registration Number: NCT03395665
• Lead Sponsor: Institut Universitari Dexeus

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01
• Primary Completion: 2017-12
• Study Completion: 2018-01
• Study First Submitted: 2018-01-04
• Study First Submitted QC: 2018-01-04
• Study First Posted: 2018-01-10
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-27
• Last Update Posted: 2018-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 299

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Miscarriage rate	Any pregnancy loss before week 20	Miscarriage was defined as a loss following a positive pregnancy test and/or detectable Gestational sac
Pregnancy rate	6 weeks after transfer procedure
Live birth rate	Ten months after transfer procedure

Trial Locations

Locations (1)

Department of Obstetrics, Gynaecology and Reproduction Instituto Universitario Dexeus; 🇪🇸 Barcelona, Spain