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

Primary Purpose

Infertility, Female

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
personal embryo transfer
Sponsored by
Reproductive & Genetic Hospital of CITIC-Xiangya
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility, Female

Eligibility Criteria

20 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

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).

Sites / Locations

  • Reproductive & Genetic Hospital of CITIC-XIANGYA

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

RIF group

Arm Description

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 .

Outcomes

Primary Outcome Measures

clinical pregnancy rate
clinical pregnancy rate

Secondary Outcome Measures

Biochemical pregnancy
Biochemical pregnancy

Full Information

First Posted
July 17, 2017
Last Updated
January 9, 2022
Sponsor
Reproductive & Genetic Hospital of CITIC-Xiangya
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1. Study Identification

Unique Protocol Identification Number
NCT03222882
Brief Title
Transcriptomic Profile of Endometrium in Different Histological Dating of Hormone Replacement Cycle
Official Title
Transcriptomic Profile of Endometrium in Different Histological Dating of Hormone Replacement Cycle
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
July 17, 2017 (Actual)
Primary Completion Date
February 28, 2019 (Actual)
Study Completion Date
March 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Reproductive & Genetic Hospital of CITIC-Xiangya

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility, Female

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
143 (Actual)

8. Arms, Groups, and Interventions

Arm Title
RIF group
Arm Type
Experimental
Arm Description
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
Intervention Name(s)
personal embryo transfer
Intervention Description
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 .
Primary Outcome Measure Information:
Title
clinical pregnancy rate
Description
clinical pregnancy rate
Time Frame
at least one intrauterine gestational sac with cardiac action by ultrasound performed 28 days after embryo transfer
Secondary Outcome Measure Information:
Title
Biochemical pregnancy
Description
Biochemical pregnancy
Time Frame
14 days after embryo transfer

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
yuan li
Organizational Affiliation
Reproductive & Genetic Hospital of CITIC-Xiangya
Official's Role
Study Chair
Facility Information:
Facility Name
Reproductive & Genetic Hospital of CITIC-XIANGYA
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410000
Country
China

12. IPD Sharing Statement

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

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