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

NCT04455191 | Unknown

• 1 other identifier: JianCH-RM2020-001
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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?

Conditions

In Vitro Fertilization; Frozen Embryo Transfer

Keywords

Frozen embryos; Thawing

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Thawing Embryos in Advance

EXPERIMENTAL

Thawing embryos one day in advance (16:00), 18h before embryos transfer (10:00).

Procedure: Thawing Embryos in Advance

Thawing Embryos on the Day of Transfer

EXPERIMENTAL

Thawing embryos on the day of transfer (8:00), 2h before embryos transfer (10:00).

Procedure: Thawing Embryos on the Day of Transfer

Interventions

Thawing Embryos in Advance PROCEDURE

Thaw Embryos one day in Advance

Thawing Embryos in Advance

Thawing Embryos on the Day of Transfer PROCEDURE

Thaw Embryos on the morning of transfer day.

Thawing Embryos on the Day of Transfer

Eligibility Criteria

• Age: 25 Years - 35 Years
• Gender Eligibility Details: Women in childbearing age intend to do IVF-FET
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jinan Central Hospital: lead

Study Sites (1)

Jinan Central Hospital Affiliated to Shandong University

Jinan, Shandong, 250013, China

Location

Study Officials

• Yingchun Zhang, Dr

  Jinan Central Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Reproductive medicine department

Study Record Dates

• First Submitted: June 28, 2020
• First Posted: July 2, 2020
• Study Start: January 1, 2020
• Primary Completion: May 31, 2021
• Study Completion: June 30, 2021
• Last Updated: July 7, 2020

Record last verified: 2020-06

Locations

CN (1)