NCT03910582

Brief Summary

The endometrium becomes receptive as a result of a series of timed hormonal events during the menstrual cycle. The exposure of the endometrium to progesterone after ovulation initiates morphological and functional alterations that result in the change from a pre-receptive to a receptive endometrium. 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" However, the clinical application of the Noyes criterion is relatively limited. We have verified the Noyes criterion in natural cycle in previous study which conducting endometrial biopsies respectively on day 3, 5, 7, 9 and 11 of post-ovulation (PO+3/5/7/9/11)(unpublished data). The clinical value of the endometrial histological dating in RIF patients in natural cycle is still to be answered. In this study, we tried to investigate the clinical effects of pFET in unexplained RIF patients according to the use of classic histologic endometrial dating to estimate the timing of the window of implantation and to adjust embryo transfer time in natural cycle.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
117

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2020

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 9, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 10, 2019

Completed
1.4 years until next milestone

Study Start

First participant enrolled

September 15, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 10, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 10, 2021

Completed
Last Updated

March 27, 2020

Status Verified

March 1, 2020

Enrollment Period

7 months

First QC Date

April 9, 2019

Last Update Submit

March 25, 2020

Conditions

Infertility, Female

Outcome Measures

Primary Outcomes (1)

  • ongoing clinical rate

    Ongoing pregnancy was defined as at least one intrauterine gestational sac with cardiac action by ultrasound performed 6 weeks after ET.

    6 weeks

Secondary Outcomes (3)

  • implantation rate

    2 weeks

  • clinical pregnancy rate

    4 weeks

  • early abortion rate

    6 weeks

Study Arms (2)

Experimental group

EXPERIMENTAL

Subjects in this group will be treated with personalized frozen-thawed embryo transfer. The blastocysts were delayed or advanced transferred after ovulation depending on the endometrium dating in RIF group

Procedure: personalized frozen-thawed embryo transfer

Control group

ACTIVE COMPARATOR

Subjects in this group will be treated with routine frozen-thawed embryo transfer.The blastocysts were transferred 5 days after ovulation regardless of endometrium dating in control group.

Procedure: routine frozen-thawed embryo transfer

Interventions

personalized frozen-thawed embryo transferPROCEDURE

The blastocysts were delayed or advanced transferred after ovulation depending on the endometrium dating in RIF group

Experimental group
routine frozen-thawed embryo transferPROCEDURE

The blastocysts were transferred 5 days after ovulation regardless of endometrium dating in control group.

Control group

Eligibility Criteria

Age20 Years - 38 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • RIF patients (RIF is defined as the absence of a gestational sac on ultrasound at 5 or more weeks after 3 embryo transfers with high quality embryos or after the transfer of ≥10 embryos in multiple transfers);
  • Out of phase dating patients;
  • FET in natural cycle;
  • Single blastocysts embryo transfer;

You may not qualify if:

  • \. uterine abnormalities (double uterus, bicornuate uterus, unicornuate uterus and uterine mediastinum), intrauterine adhesions, endometriosis,adenomyosis, hydrosalpinx, and uterine fibroids (submucosal fibroids, non-mucosal fibroids\> 4 cm and/or endometrial pressure);

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Infertility, Female

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesInfertility

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 9, 2019

First Posted

April 10, 2019

Study Start

September 15, 2020

Primary Completion

April 10, 2021

Study Completion

June 10, 2021

Last Updated

March 27, 2020

Record last verified: 2020-03