Estradiol, Progesterone and Endometrial Thickness in Frozen Euploid Embryo Transfer

Sponsor

Institut Universitari Dexeus (Other)

Overall Status

Completed

CT.gov ID

NCT03395665

Collaborator

(none)

299

Enrollment

Location

Actual Duration (Months)

6.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Infertility Preimplantation Genetic Diagnosis/Screening Miscarriage	Other: Estradiol level Other: Progesterone level Other: Endometrial thickness

Study Design

Study Type:

Observational

Actual Enrollment :

299 participants

Observational Model:

Case-Crossover

Time Perspective:

Retrospective

Official Title:

Estradiol, Progesterone and Endometrial Thickness in Frozen Euploid Embryo Transfer

Actual Study Start Date :

Jan 1, 2014

Actual Primary Completion Date :

Dec 1, 2017

Actual Study Completion Date :

Jan 1, 2018

Outcome Measures

Primary Outcome Measures

Live birth rate [Ten months after transfer procedure]
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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 43 Years

Sexes Eligible for Study:

Female

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Obstetrics, Gynaecology and Reproduction Instituto Universitario Dexeus	Barcelona		Spain	08028

Sponsors and Collaborators

Institut Universitari Dexeus

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Related Info

Publications

None provided.

Responsible Party:

Buenaventura Coroleu, Head of Reproductive Medicine Service, Institut Universitari Dexeus

ClinicalTrials.gov Identifier:

NCT03395665

Other Study ID Numbers:

SMD-2018-01

First Posted:

Jan 10, 2018

Last Update Posted:

Feb 28, 2018

Last Verified:

Feb 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Infertility

Abortion, Spontaneous

Estradiol

Progesterone

Study Results

No Results Posted as of Feb 28, 2018