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

R

Reproductive & Genetic Hospital of CITIC-Xiangya

Status

Completed

Conditions

Infertility, Female

Treatments

Procedure: personal embryo transfer

Study type

Interventional

Funder types

Other

Identifiers

NCT03222882
KYXM-201702-01

Details and patient eligibility

About

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.

Enrollment

143 patients

Sex

Female

Ages

20 to 40 years old

Volunteers

No 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).

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

143 participants in 1 patient group

RIF group
Experimental group
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 .
Treatment:
Procedure: personal embryo transfer

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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