Estradiol, Progesterone and Endometrial Thickness in Frozen Euploid Embryo Transfer

NCT03395665 | Completed

• 1 other identifier: SMD-2018-01
• Study Type: observational
• Target: 299
• Locations: 1 country
• Sites: 1

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.

Conditions

Infertility; Preimplantation Genetic Diagnosis/Screening; Miscarriage

Outcome Measures

Primary Outcomes (3)

• Live birth rate

  Ten months after transfer procedure

• Miscarriage rate

  Miscarriage was defined as a loss following a positive pregnancy test and/or detectable Gestational sac

  Any pregnancy loss before week 20

• Pregnancy rate

  6 weeks after transfer procedure

Interventions

Estradiol level OTHER

Estradiol level measured at previous day of embryo transfer procedure

Progesterone level OTHER

Progesterone level measured at previous day of embryo transfer procedure

Endometrial thickness OTHER

Endometrial thickness measured at previous day of embryo transfer procedure

Eligibility Criteria

• Age: 18 Years - 43 Years
• Sex: female
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Women who underwent blastocyst trophectoderm biopsy and PGS and frozen-thawed embryo transfers(PGS-FET) performed after the In Vitro Fertilization (IVF) . PGS was implemented as 46-chromosome screening, using array comparative genomic hybridization (aCGH) from Day 5 trophectoderm biopsy. Whole-genome amplification, processing and analyses were performed using the kits, software and protocols for array Comparative Genomic Hybridisation (aCGH) analysis provided by the manufacturer (SurePlex® DNA Amplification System, 24Sure® Microarray Pack, Bluefuse®, Illlumina®).

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Fundacion Dexeus: lead

Study Sites (1)

Department of Obstetrics, Gynaecology and Reproduction Instituto Universitario Dexeus

Barcelona, 08028, Spain

Location

Related Links

• Related Info

MeSH Terms

Conditions

Infertility; Abortion, Spontaneous

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Reproductive Medicine Service

Study Record Dates

• First Submitted: January 4, 2018
• First Posted: January 10, 2018
• Study Start: January 1, 2014
• Primary Completion: December 1, 2017
• Study Completion: January 1, 2018
• Last Updated: February 28, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)