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

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ClinicalTrials.gov Identifier: NCT03312309
Recruitment Status : Recruiting
First Posted : October 17, 2017
Last Update Posted : November 17, 2017
Sponsor:
Information provided by (Responsible Party):
Reproductive & Genetic Hospital of CITIC-Xiangya

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
Infertility, Female Procedure: personal embryo transfer Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
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 : October 17, 2017
Estimated Primary Completion Date : December 31, 2017
Estimated Study Completion Date : June 30, 2018

Resource links provided by the National Library of Medicine


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.





Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Biochemical pregnancy [ Time Frame: 14 days after embryo transfer ]
    Biochemical pregnancy



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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03312309


Contacts
Contact: yuan li, doctor +86-731-82355100 1002251255@qq.com

Locations
China, Hunan
Reproductive & Genetic Hospital of CITIC-XIANGYA Recruiting
Changsha, Hunan, China, 410000
Contact: yuan li    +86-731-82355100    1002251255@qq.com   
Sponsors and Collaborators
Reproductive & Genetic Hospital of CITIC-Xiangya
Investigators
Study Chair: yuan li, doctor Reproductive & Genetic Hospital of CITIC-Xiangya

Responsible Party: Reproductive & Genetic Hospital of CITIC-Xiangya
ClinicalTrials.gov Identifier: NCT03312309     History of Changes
Other Study ID Numbers: KYXM-201702-02
First Posted: October 17, 2017    Key Record Dates
Last Update Posted: November 17, 2017
Last Verified: November 2017

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

Additional relevant MeSH terms:
Infertility
Infertility, Female
Genital Diseases, Male
Genital Diseases, Female
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs