NCT03222830

Brief Summary

At present, the evaluation criterion of endometrial receptivity is controversial. The development of a molecular diagnostic tool, the endometrial receptivity array (ERA) for diagnosis of endometrial receptivity . But use of this test in patients with RIF has shown that the window of implantation (WOI) is displaced in only a quarter of these patients and use of a personalized embryo transfer (pET) on the day designated by ERA improves reproductive performance with higher cost .what is known to the others'population? The morphological changes observed on histology for each specific day after ovulation were described by Noyes and his colleagues in 1950 . An endometrial biopsy that shows a difference of more than 2 days between the histologic dating and actual day after ovulation is considered to be ''out of phase''. But such pET studies according to the Noyes criterion are lacking . The aim of this study is to explore the transcriptomic profile of endometrial receptivity in different histological dating of natural cycle and its clinical application.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 17, 2017

Completed
Same day until next milestone

Study Start

First participant enrolled

July 17, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 19, 2017

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2018

Completed
Last Updated

January 11, 2022

Status Verified

January 1, 2022

Enrollment Period

9 months

First QC Date

July 17, 2017

Last Update Submit

January 9, 2022

Conditions

Infertility, Female

Outcome Measures

Primary Outcomes (1)

  • clinical pregnancy rate

    clinical pregnancy rate

    at least one intrauterine gestational sac with cardiac action by ultrasound performed 28 days after embryo transfer

Secondary Outcomes (1)

  • Biochemical pregnancy

    14 days after embryo transfer

Study Arms (1)

RIF group

EXPERIMENTAL

According to the histological dating and transcriptomic profile of endometrium of natural cycle in control group, to explore the effectiveness of intervention by advanced or delayed personal embryo transfer . The establishment of standard control group: Frozen embryo transfer patients according to the inclusion and exclusion criteria were evaluated for histological dating and transcriptomic profile by endometrial biopsy on 7 days after ovulation. After routine time transfer in the frozen embryo transfer cycle, the standard of histological dating and transcriptomic profile were determined according to the pregnancy. outcome of the FET cycle .

Procedure: personal embryo transfer

Interventions

personal embryo transferPROCEDURE

According to the histological dating and transcriptomic profile of endometrium of natural cycle in control group, to explore the effectiveness of intervention by advanced or delayed personal embryo transfer . The establishment of standard control group: Frozen embryo transfer patients according to the inclusion and exclusion criteria were evaluated for histological dating and transcriptomic profile by endometrial biopsy on 7 days after ovulation. After routine time transfer in the frozen embryo transfer cycle, the standard of histological dating and transcriptomic profile were determined according to the pregnancy. outcome of the FET cycle .

RIF group

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may not qualify if:

  • (1) uterine abnormalities (double uterus, bicornuate uterus, unicornuate uterus); (2) intrauterine adhesions（moderate - severe）, endometriosis, adenomyosis, untreated hydrosalpinx, uterine fibroids (submucosal fibroids, nonmucosal fibroids \>4.0 cm and/or endometrial pressure) (3) history of adverse pregnancy (including spontaneous abortion, stillbirth, and fetal malformation).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Reproductive & Genetic Hospital of CITIC-XIANGYA

Changsha, Hunan, 410000, China

Location

Related Publications (1)

  • Li Y, Li XF, Liao JN, Fan XX, Hu YB, Gan R, Lu G, Lin G, Gong F. Clinical value of histologic endometrial dating for personalized frozen-thawed embryo transfer in patients with repeated implantation failure in natural cycles. BMC Pregnancy Childbirth. 2020 Sep 11;20(1):527. doi: 10.1186/s12884-020-03217-y.

    PMID: 32917168DERIVED

MeSH Terms

Conditions

Infertility, Female

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesInfertility

Study Officials

  • yuan li

    Reproductive & Genetic Hospital of CITIC-Xiangya

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 17, 2017

First Posted

July 19, 2017

Study Start

July 17, 2017

Primary Completion

March 30, 2018

Study Completion

March 30, 2018

Last Updated

January 11, 2022

Record last verified: 2022-01

Locations

CN(1)