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A Study:the Different Outcomes Between Natural Cycle and Hormone Replacement Cycle in FET

Primary Purpose

Infertility

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
natural cycles
estradiol and progesterone
Sponsored by
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility focused on measuring endometrium preparation protocols, frozen-thawed embryo transfer, natural cycles, hormone replacement therapy cycles, randomized controlled trial

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Age forty years old or less
  • Has regulation Menstruation (cycle 24-35 days) or previous data suggest that normal ovulation
  • Frozen embryos number more than three

Exclusion Criteria:

  • Has Chocolate cyst or adenomyosis of uterus
  • Clear hydrosalpinx
  • Uterine scar or intrauterine adhesion and endometrial thickness <7mm before ovulation
  • recur thick endometrium(<7mm)
  • repeated implantation failure(≥3 times)
  • Cancel the cycle because of having no dominant follicle in the NC+FET before or the growth of endometrium not good in the HRT+FET before

Sites / Locations

  • Sun Yat-Sen Memorial HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

group NC-A

group HRT-B

Arm Description

Patients with regular cycles undergoing FET in reproductive medicine renter of Sun Yat-sen Memorial Hospital will be recruited, who should not be elder than 40 and had more than 3 frozen embryos.They will be randomized to receive the natural cycles.

Patients with regular cycles undergoing FET in reproductive medicine renter of Sun Yat-sen Memorial Hospitalwill be recruited , who should not be elder than 40 and had more than 3 frozen embryos will be randomized to receive the estradiol and progesterone replacement therapy cycles.

Outcomes

Primary Outcome Measures

Live-birth rate

Secondary Outcome Measures

pregnancy rate
2 weeks after Embryo transplantation, people go urine HCG and blood HCG test,positive as pregnancy
clinical pregnancy rate
5 weeks after Embryo transplantation,people go Vaginal B ultrasonic,being saw the gestation sac as clinical pregnancy

Full Information

First Posted
January 24, 2013
Last Updated
March 31, 2013
Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
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1. Study Identification

Unique Protocol Identification Number
NCT01780558
Brief Title
A Study:the Different Outcomes Between Natural Cycle and Hormone Replacement Cycle in FET
Official Title
A Randomized Controlled Study:the Different Outcomes Between Natural Cycle and Hormon Replacement Cycle in FET
Study Type
Interventional

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Unknown status
Study Start Date
January 2010 (undefined)
Primary Completion Date
January 2015 (Anticipated)
Study Completion Date
January 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
There are three main cycle regimens used for endometrial preparation for frozen embryo transfer(FET): natural cycles (NC) with/without ovulation triggering, hormone replacement therapy cycles (HRT) in which the endometrium is artificially prepared by estrogen and progesterone hormones with/without a gonadotrophin releasing hormone agonist (GnRH-a) down regulation, and ovulation induced cycles (OI) in which follicular development is supported with increasing doses of gonadotrophin hormones and ovulation is induced. At present, there is still no sufficient evidence that which kind of FET cycle regimen to plan more advantage. The purpose of this study was to compare the pregnancy outcome of NC-FET to that of HRT-FET in women with regular cycles.
Detailed Description
This study is a prospective randomized controlled trial. Patients with regular cycles undergoing FET in reproductive medicine renter of Sun Yat-sen Memorial Hospital will be recruited,who should not be elder than 40 and had more than 3 frozen embryos. They will be randomized to receive either the NC-FET cycle (group NC-A) or the HRT-FET cycle (group HRT-B). In group NC-A, the ovulation is monitored spontaneously or induced by human chorionic gonadotropin(HCG) when the dominant follicle is larger than 18mm without luteinizing hormone surge(LH). Transfer of thawed embryos will be performed 4 days after LH /HCG administration or 3 days after ovulation is observed. In group HRT-B, oral estradiol, 2 mg, once daily, is introduced on cycle day 3 with an increasing doses protocol. If the endometrial thickness is greater than 7mm, progesterone 40-60 mg in oil will be administered via intramuscular injection. Transfer of thawed embryos will be performed 3 days later. This study was approved by the reproductive medicine ethics committee of Sun Yet-sen Memorial Hospital.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
endometrium preparation protocols, frozen-thawed embryo transfer, natural cycles, hormone replacement therapy cycles, randomized controlled trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
group NC-A
Arm Type
Other
Arm Description
Patients with regular cycles undergoing FET in reproductive medicine renter of Sun Yat-sen Memorial Hospital will be recruited, who should not be elder than 40 and had more than 3 frozen embryos.They will be randomized to receive the natural cycles.
Arm Title
group HRT-B
Arm Type
Other
Arm Description
Patients with regular cycles undergoing FET in reproductive medicine renter of Sun Yat-sen Memorial Hospitalwill be recruited , who should not be elder than 40 and had more than 3 frozen embryos will be randomized to receive the estradiol and progesterone replacement therapy cycles.
Intervention Type
Other
Intervention Name(s)
natural cycles
Other Intervention Name(s)
spontaneous ovulation cycles
Intervention Description
the ovulation is monitored spontaneously or induced by HCG when the dominant follicle is larger than 18mm without LH surge. Transfer of thawed embryos will be performed 4 days after LH surge/HCG administration or 3 days after ovulation is observed.
Intervention Type
Drug
Intervention Name(s)
estradiol and progesterone
Other Intervention Name(s)
Estradiol Valerate, Progynova, corpus luteum hormone, luteal hormone
Intervention Description
oral estradiol, 2 mg, once daily, is introduced on cycle day 3 with an increasing doses protocol. If the endometrial thickness is greater than 7mm, progesterone 40-60 mg in oil will be administered via intramuscular injection. Transfer of thawed embryos will be performed 3 days later.
Primary Outcome Measure Information:
Title
Live-birth rate
Time Frame
Live-birth after FET
Secondary Outcome Measure Information:
Title
pregnancy rate
Description
2 weeks after Embryo transplantation, people go urine HCG and blood HCG test,positive as pregnancy
Time Frame
2 weeks after Embryo transplantation
Title
clinical pregnancy rate
Description
5 weeks after Embryo transplantation,people go Vaginal B ultrasonic,being saw the gestation sac as clinical pregnancy
Time Frame
5 weeks after Embryo transplantation

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age forty years old or less Has regulation Menstruation (cycle 24-35 days) or previous data suggest that normal ovulation Frozen embryos number more than three Exclusion Criteria: Has Chocolate cyst or adenomyosis of uterus Clear hydrosalpinx Uterine scar or intrauterine adhesion and endometrial thickness <7mm before ovulation recur thick endometrium(<7mm) repeated implantation failure(≥3 times) Cancel the cycle because of having no dominant follicle in the NC+FET before or the growth of endometrium not good in the HRT+FET before
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhang qixue, professor
Phone
13602737433
Email
zhangqingxue666@yahoo.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhang qingxue, doctor
Organizational Affiliation
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Official's Role
Study Director
Facility Information:
Facility Name
Sun Yat-Sen Memorial Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhang qingxue, doctor
Phone
13602797433
Email
zhangqingxue666@yahoo.cn

12. IPD Sharing Statement

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A Study:the Different Outcomes Between Natural Cycle and Hormone Replacement Cycle in FET

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