Personal FET in RIF Patients According to Histological Dating of Endometrial of Natural/ Hormone Replacement Cycle

Sponsor
Reproductive & Genetic Hospital of CITIC-Xiangya (Other)
Overall Status
Completed
CT.gov ID
NCT03312309
Collaborator
(none)
155
1
1
4.4
35.2

Study Details

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 are lacking . The aim of this study is to explore the Personal frozen-thawed embryo transfer in unexplained RIF patients according to the blinded histological dating of endometrial biopsies .

Condition or Disease Intervention/Treatment Phase
  • Procedure: personal embryo transfer
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
155 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Personal Frozen-thawed Embryo Transfer in Unexplained RIF Patients According to the Blinded Histological Dating of Endometrial Biopsies of Natural/ Hormone Replacement Cycle
Actual Study Start Date :
Oct 17, 2017
Actual Primary Completion Date :
Dec 31, 2017
Actual Study Completion Date :
Feb 28, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: RIF group

According to the histological dating of endometrium of natural/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 by endometrial biopsy on 7 days after ovulation/P+7. After routine time transfer in the frozen embryo transfer cycle, the standard of histological dating were determined according to the pregnancy outcome of the FET cycle . pET in RIF patients was delayed one(ovulation +4/P+4, OV/P+4) / two days(OV/P+3) or advanced one day(OV/P+9). Day 5 blastocysts were transferred with this strategy in natural cycles.

Procedure: personal embryo transfer
According to the histological dating of endometrium of natural/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 by endometrial biopsy on 7 days after ovulation/P+7. After routine time transfer in the frozen embryo transfer cycle, the standard of histological dating were determined according to the pregnancy outcome of the FET cycle . pET in RIF patients was delayed one(ovulation +4/P+4, OV/P+4) / two days(OV/P+3) or advanced one day(OV/P+9). Day 5 blastocysts were transferred with this strategy in natural cycles.

Outcome Measures

Primary Outcome Measures

  1. clinical pregnancy rate [at least one intrauterine gestational sac with cardiac action by ultrasound performed 28 days after embryo transfer]

    clinical pregnancy rate

Secondary Outcome Measures

  1. Biochemical pregnancy [14 days after embryo transfer]

    Biochemical pregnancy

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 40 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:
The inclusion criteria for RIF group were:

•unexplained repeated implantation failure (RIF) which 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:
  • age <35 years;

  • regular menstrual cycles of 24-35 days;

  • baseline follicle- stimulating hormone (FSH) < 9.0 IU/L;

  • endometrial thickness ≥8.0 mm on the day of hCG administration.

Exclusion Criteria:
  • uterine abnormalities (double uterus, bicornuate uterus, unicornuate uterus);

  • intrauterine adhesions(moderate - severe), endometriosis, adenomyosis, untreated hydrosalpinx, uterine fibroids (submucosal fibroids, nonmucosal fibroids >4.0 cm and/or endometrial pressure)

  • history of adverse pregnancy (including spontaneous abortion, stillbirth, and fetal malformation).

Contacts and Locations

Locations

Site City State Country Postal Code
1 Reproductive & Genetic Hospital of CITIC-XIANGYA Changsha Hunan China 410000

Sponsors and Collaborators

  • Reproductive & Genetic Hospital of CITIC-Xiangya

Investigators

  • Study Chair: yuan li, doctor, Reproductive & Genetic Hospital of CITIC-Xiangya

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Reproductive & Genetic Hospital of CITIC-Xiangya
ClinicalTrials.gov Identifier:
NCT03312309
Other Study ID Numbers:
  • KYXM-201702-02
First Posted:
Oct 17, 2017
Last Update Posted:
Jan 11, 2022
Last Verified:
Jan 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 11, 2022