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

NCT ID: NCT03312309

Last Updated: 2022-01-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 155 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-17
• Study Completion Date: 2018-02-28

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

personal embryo transfer

Intervention Type: 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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

•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.

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).

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Reproductive & Genetic Hospital of CITIC-Xiangya

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

yuan li, doctor

Role: STUDY_CHAIR

Reproductive & Genetic Hospital of CITIC-Xiangya

Locations

Reproductive & Genetic Hospital of CITIC-XIANGYA

Changsha, Hunan, China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 32917168 (View on PubMed)

Other Identifiers

KYXM-201702-02

Identifier Type: -

Identifier Source: org_study_id