Personalized FET in RIF Patients With Displaced Dating

Infertility, Female Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03910582
• Other study ID #: P2019003
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 15, 2020
• Est. completion date: June 10, 2021

Study information

• Verified date: March 2020
• Source: Reproductive & Genetic Hospital of CITIC-Xiangya
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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study which conducting endometrial biopsies respectively on day 3, 5, 7, 9 and 11 of post-ovulation (PO+3/5/7/9/11)(unpublished data).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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 117
• Est. completion date: June 10, 2021
• Est. primary completion date: April 10, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 38 Years

Eligibility

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);

Related Conditions & MeSH terms

• Infertility
• Infertility, Female

Intervention

Procedure:
• personalized frozen-thawed embryo transfer
The blastocysts were delayed or advanced transferred after ovulation depending on the endometrium dating in RIF group
• routine frozen-thawed embryo transfer
The blastocysts were transferred 5 days after ovulation regardless of endometrium dating in control group.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Reproductive & Genetic Hospital of CITIC-Xiangya

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	implantation rate		2 weeks
Secondary	clinical pregnancy rate		4 weeks
Secondary	early abortion rate		6 weeks