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Clinical Trials/NCT03222830
NCT03222830CompletedNot Applicable

Transcriptomic Profile of Endometrium in Different Histological Dating of Natural Cycle

Reproductive & Genetic Hospital of CITIC-Xiangya1 site in 1 country50 target enrollmentStarted: July 17, 2017Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
50
Locations
1
Primary Endpoint
clinical pregnancy rate

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
20 Years to 40 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
No

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) regular menstrual cycles of 24-35 days; (3) baseline follicle- stimulating hormone (FSH) < 9.0 IU/L; (4) endometrial thickness ≥8.0 mm on the day of hCG administration.

Exclusion Criteria

  • (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).

Outcomes

Primary Outcomes

clinical pregnancy rate

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

clinical pregnancy rate

Secondary Outcomes

  • Biochemical pregnancy(14 days after embryo transfer)

Investigators

Sponsor
Reproductive & Genetic Hospital of CITIC-Xiangya
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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