Transcriptomic Profile of Endometrium in Different Histological Dating of Hormone Replacement Cycle

NCT ID: NCT03222882

Last Updated: 2022-01-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

143 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-17

Study Completion Date

2019-03-31

Brief Summary

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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 in hormone replacement cycle are lacking . The aim of this study is to explore the transcriptomic profile of endometrial receptivity in different histological dating of hormone replacement cycle and its clinical application.

Detailed Description

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Conditions

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Infertility, Female

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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RIF group

According to the histological dating and transcriptomic profile of endometrium of hormone replacement 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 day P+7 in an HRT cycle. 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 .

Group Type EXPERIMENTAL

personal embryo transfer

Intervention Type PROCEDURE

According to the histological dating and transcriptomic profile of endometrium of hormone replacement 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 day P+7 in an HRT cycle. 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 .

Interventions

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personal embryo transfer

According to the histological dating and transcriptomic profile of endometrium of hormone replacement 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 day P+7 in an HRT cycle. 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 .

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

Inclusion Criteria:

* The inclusion criteria for RIF group were: unexplained repeated implantation failure (RIF) is defined as the absence of a gestational sac on ultrasound at 5 or more weeks after embryo transfer (ET) after 3 embryo transfers with high quality embryos or after the transfer of ≥10 embryos in multiple transfers.

The inclusion criteria for control group were: (1) age \<35 years; (2) unregular menstrual cycles of \>37 days; (3) baseline follicle- stimulating hormone (FSH) \< 9.0 IU/L; (4) endometrial thickness ≥7.0 mm on the day of hCG administration.

Exclusion Criteria:

* The exclusion criteria were: (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).
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Reproductive & Genetic Hospital of CITIC-Xiangya

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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yuan li

Role: STUDY_CHAIR

Reproductive & Genetic Hospital of CITIC-Xiangya

Locations

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Reproductive & Genetic Hospital of CITIC-XIANGYA

Changsha, Hunan, China

Site Status

Countries

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China

Other Identifiers

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KYXM-201702-01

Identifier Type: -

Identifier Source: org_study_id

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