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The Effects of Two Endometrium Preparation Protocols in Frozen-thawed Embryo Transfer in Women With Irregular Cycles

Primary Purpose

Infertility

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Letrozole and human chorionic gonadotrophin
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, irregular cycle, randomized controlled trial

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Age forty years old or less
  • Has irregular Menstruation (cycle more than 35 days or less than 24 days ) or has regulation Menstruation but previous data suggest that abnormal 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 ovulation induction(OI)+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 OI-A

group HRT-B

Arm Description

Patients with irregular 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 Letrozole and human chorionic gonadotrophin ovulation induced cycles.

Patients with irregular 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 will be randomized to receive the estradiol and progesterone replacement therapy cycles.

Outcomes

Primary Outcome Measures

ongoing pregnancy rate
12 weeks after pregnancy,people go Vaginal B ultrasonic examination,being saw gestational sac and heart tube beat as ongoing pregnancy

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
NCT01780610
Brief Title
The Effects of Two Endometrium Preparation Protocols in Frozen-thawed Embryo Transfer in Women With Irregular Cycles
Official Title
The Effects of Two Endometrium Preparation Protocols in Frozen-thawed Embryo Transfer in Women With Irregular Cycles
Study Type
Interventional

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Unknown status
Study Start Date
January 2012 (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 two main cycle regimens used for endometrial preparation for frozen embryo transfer (FET) in women with irregular cycles: 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 frozen embryo transfer cycle regimen to plan more advantage. The purpose of this study was to compare the pregnancy outcome of hormone replacement therapy cycles (HRT) and ovulation induced cycles (OI) in women with irregular cycles.
Detailed Description
This study is a prospective randomized controlled trial. Patients with irregular 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 OI-FET cycle (group OI-A) or the HRT-FET cycle (group HRT-B). In group OI-A, the follicular development is supported by Letrozole(LE) 2.5mg,once daily,is introduced on cycle day 3 .And on cycle day 10 , a Vagina ultrasound is introduced to monitor the development of the follicular ,following by intramuscular gonadotrophin 37.5~75 IU/d until there is a Luteinizing Hormone(LH) surge or ovulation .On the day appearing Luteinizing Hormone surge,patient is always introduced intramuscular human chorionic gonadotrophin(HCG) 10000 IU.If there is sill no Luteinizing Hormone surge when the follicle is 20-24mm ,the ovulation will be induced by HCG.Then the luteum is supported by HCG 2000-2500 IU/3d.Transfer of thawed embryos will be performed 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.

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, irregular cycle, randomized controlled trial

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
group OI-A
Arm Type
Other
Arm Description
Patients with irregular 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 Letrozole and human chorionic gonadotrophin ovulation induced cycles.
Arm Title
group HRT-B
Arm Type
Other
Arm Description
Patients with irregular 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 will be randomized to receive the estradiol and progesterone replacement therapy cycles.
Intervention Type
Drug
Intervention Name(s)
Letrozole and human chorionic gonadotrophin
Other Intervention Name(s)
Letrozole tablets, HCG, Chorionic gonadotrophin, Chorionic gonadotropic hormone
Intervention Description
the follicular development is supported by Letrozole(LE) 2.5mg,once daily is introduced on cycle day 3 .And on cycle day 10 , a Vagina ultrasound is introduced to monitor the development of the follicular ,following by intramuscular gonadotrophin 37.5~75 IU/d until there is a Luteinizing Hormone(LH) surge or ovulation .On the day appearing Luteinizing Hormone surge,patients is always introduced intramuscular human chorionic gonadotrophin(HCG) 10000 IU.If there is sill no Luteinizing Hormone surge when the follicle is 20-24mm ,the ovulation will be induced by HCG.Then the luteum was supported by HCG 2000-2500 IU/3d.Transfer of thawed embryos will be performed 3 days after ovulation is observed.
Intervention Type
Drug
Intervention Name(s)
estradiol and progesterone
Other Intervention Name(s)
Estradiol Valerate, Progynova, 3,20-pregnene-4; 4-pregnene-3,20-dione, corpus luteum hormone, luteal hormone
Intervention Description
oral estradiol, 2 mg, once daily, was introduced on cycle day 3 with an increasing doses protocol. If the endometrial thickness was greater than 7mm, progesterone 40-60 mg in oil was administered via intramuscular injection. Transfer of thawed embryos was performed 3 days later
Primary Outcome Measure Information:
Title
ongoing pregnancy rate
Description
12 weeks after pregnancy,people go Vaginal B ultrasonic examination,being saw gestational sac and heart tube beat as ongoing pregnancy
Time Frame
12 weeks after pregnancy
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 irregular Menstruation (cycle more than 35 days or less than 24 days ) or has regulation Menstruation but previous data suggest that abnormal 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 ovulation induction(OI)+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
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

12. IPD Sharing Statement

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The Effects of Two Endometrium Preparation Protocols in Frozen-thawed Embryo Transfer in Women With Irregular Cycles

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