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

NCT03312309 | Completed

• 1 other identifier: KYXM-201702-02
• Study Type: interventional
• Target: 155
• Locations: 1 country
• Sites: 1

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 .

Conditions

Infertility, Female

Outcome Measures

Primary Outcomes (1)

• clinical pregnancy rate

  clinical pregnancy rate

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

Secondary Outcomes (1)

• Biochemical pregnancy

  14 days after embryo transfer

Study Arms (1)

RIF group

EXPERIMENTAL

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

Interventions

personal embryo transfer PROCEDURE

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.

RIF group

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Reproductive & Genetic Hospital of CITIC-Xiangya: lead

Study Sites (1)

Reproductive & Genetic Hospital of CITIC-XIANGYA

Changsha, Hunan, 410000, China

Location

Related Publications (1)

• Li Y, Li XF, Liao JN, Fan XX, Hu YB, Gan R, Lu G, Lin G, Gong F. Clinical value of histologic endometrial dating for personalized frozen-thawed embryo transfer in patients with repeated implantation failure in natural cycles. BMC Pregnancy Childbirth. 2020 Sep 11;20(1):527. doi: 10.1186/s12884-020-03217-y.

  PMID: 32917168 DERIVED

MeSH Terms

Conditions

Infertility, Female

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Infertility

Study Officials

• yuan li, doctor

  Reproductive & Genetic Hospital of CITIC-Xiangya

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2017
• First Posted: October 17, 2017
• Study Start: October 17, 2017
• Primary Completion: December 31, 2017
• Study Completion: February 28, 2018
• Last Updated: January 11, 2022

Record last verified: 2022-01

Locations

CN (1)