Comparison of Thawing Embryos in Advance and on the Day of Transfer on Pregnancy Outcomes in FET Cycle

In Vitro Fertilization Clinical Trial

Official title:

Comparison of the Effects of Thawing Embryos in Advance and Thawing on the Day of Transfer on Pregnancy Outcomes in the Frozen Embryo Transfer Cycle

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04455191
• Other study ID #: JianCH-RM2020-001
• Status: Enrolling by invitation
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: June 30, 2021

Study information

• Verified date: June 2020
• Source: Jinan Central Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Respectively for patients with repeated transplant failure and routine patients, Thawing frozen embryos in advance (18h) to extend the duration of embryonic development or thawing embryos on the day of transfer in the frozen embryo transfer cycle, to analyze which way can improve clinical pregnancy outcomes, is there a significant difference between the two ways or two types of patients?

Description:

Although in clinical practice, thawed embryos with appropriate development time will be selected strictly according to the number of days after ovulation, there are still two problems in actual clinical treatment: one is the embryonic factor, although the rate of embryonic development is generally the same, However, the phenomenon of delayed embryo division and development often occurs. The second is the endometrial factor. There are reports that a small number of people will move the transplant window forward, or the transplant window is narrow. This potentially creates the risk of embryo-endometrial mismatch. Based on this, the research team focused on patients with frozen embryo transfer cycles and put forward the strategy of "thawing embryos in advance and prolonging the development period of embryos properly" in an effort to achieve better repair of damage caused by embryo freezing and fine-tuning of embryo-endometrial interaction time. Therefore, it is necessary to compare thawing embryos in advance and thawing on the day of transfer on pregnancy outcomes in patients with repeated transplant failure and routine patients respectively.

The purpose of this study is to analyze which way can improve clinical pregnancy and birth outcomes, is there a significant difference between the two ways or two types of patients?

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 500
• Est. completion date: June 30, 2021
• Est. primary completion date: May 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 25 Years to 35 Years

Eligibility

Inclusion Criteria:

• Aged <=35 years old;

• Regular menstrual cycle;

• Baseline follicle stimulating hormone (FSH) <12 IU/L;

• Infertility, pure fallopian tube or/and male factor;

• At least 2 high-quality day 3 embryos or 1 high-quality day 5 blastocyst are used for ET.

Exclusion Criteria:

• Patients with repeated transplant failure:

• Abnormal uterus, such as adenomyosis, endometriosis, endometrial polyps or Asherman syndrome;

• Abnormal ovaries, such as low ovarian response and polycystic ovary syndrome (PCOS);

• The endometrial thickness of FET day is <7 mm.

Related Conditions & MeSH terms

• Frozen Embryo Transfer
• In Vitro Fertilization

Intervention

Procedure:
• Thawing Embryos in Advance
Thaw Embryos one day in Advance
• Thawing Embryos on the Day of Transfer
Thaw Embryos on the morning of transfer day.

Locations

Country	Name	City	State
China	Jinan Central Hospital Affiliated to Shandong University	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Jinan Central Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Pregnancy Rate (Pregnancy or Not)	Observe the clinical pregnancy rate under different embryo thawing time	6 weeks
Primary	Live Birth Rate (Birth or Not)	Observe the live birth rate under different embryo thawing time	40 weeks