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

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

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?

Study Overview

• Status: Unknown
• Conditions: In Vitro Fertilization; Frozen Embryo Transfer
• Intervention / Treatment: Procedure: Thawing Embryos in Advance; Procedure: Thawing Embryos on the Day of Transfer

Detailed 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?

• Study Type: Interventional
• Enrollment (Anticipated): 500
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China, 250013
      • Jinan Central Hospital Affiliated to Shandong University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Thawing Embryos in Advance; Thawing embryos one day in advance (16:00), 18h before embryos transfer (10:00).	Procedure: Thawing Embryos in Advance; Thaw Embryos one day in Advance
Experimental: Thawing Embryos on the Day of Transfer; Thawing embryos on the day of transfer (8:00), 2h before embryos transfer (10:00).	Procedure: Thawing Embryos on the Day of Transfer; Thaw Embryos on the morning of transfer day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Pregnancy Rate (Pregnancy or Not)	Observe the clinical pregnancy rate under different embryo thawing time	6 weeks
Live Birth Rate (Birth or Not)	Observe the live birth rate under different embryo thawing time	40 weeks

Collaborators and Investigators

• Sponsor: Jinan Central Hospital
• Investigators: Study Director: Yingchun zhang, Dr, Jinan Central Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Anticipated): May 31, 2021
• Study Completion (Anticipated): June 30, 2021

Study Registration Dates

• First Submitted: June 28, 2020
• First Submitted That Met QC Criteria: June 28, 2020
• First Posted (Actual): July 2, 2020

Study Record Updates

• Last Update Posted (Actual): July 7, 2020
• Last Update Submitted That Met QC Criteria: July 1, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: Frozen embryos; Thawing
• Other Study ID Numbers: JianCH-RM2020-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No