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Personalized FET in RIF Patients With Displaced Dating

A Randomized Clinical Trial of Endometrial Histological Dating for Personalized Frozen-thawed Embryo Transfer (pFET) in Patients With Repeated Implantation Failure (RIF) in Natural Cycle

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03910582
Enrollment
117
Registered
2019-04-10
Start date
2020-09-15
Completion date
2021-06-10
Last updated
2020-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertility, Female

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study which conducting endometrial biopsies respectively on day 3, 5, 7, 9 and 11 of post-ovulation (PO+3/5/7/9/11)(unpublished data).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.

Interventions

PROCEDUREpersonalized frozen-thawed embryo transfer

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

PROCEDUREroutine frozen-thawed embryo transfer

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

Sponsors

Reproductive & Genetic Hospital of CITIC-Xiangya
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 38 Years
Healthy volunteers
No

Inclusion criteria

1. 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); 2. Out of phase dating patients; 3. FET in natural cycle; 4. Single blastocysts embryo transfer;

Exclusion criteria

1\. 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);

Design outcomes

Primary

MeasureTime frameDescription
ongoing clinical rate6 weeksOngoing pregnancy was defined as at least one intrauterine gestational sac with cardiac action by ultrasound performed 6 weeks after ET.

Secondary

MeasureTime frame
implantation rate2 weeks
clinical pregnancy rate4 weeks
early abortion rate6 weeks

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026