- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01780558
A Study:the Different Outcomes Between Natural Cycle and Hormone Replacement Cycle in FET
March 31, 2013 updated by: Qingxue Zhang, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
A Randomized Controlled Study:the Different Outcomes Between Natural Cycle and Hormon Replacement Cycle in FET
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
600
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Zhang qixue, professor
- Phone Number: 13602737433
- Email: zhangqingxue666@yahoo.cn
Study Locations
-
-
Guangdong
-
Guangzhou, Guangdong, China, 510000
- Recruiting
- Sun Yat-sen Memorial Hospital
-
Contact:
- Zhang qingxue, doctor
- Phone Number: 13602797433
- Email: zhangqingxue666@yahoo.cn
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 40 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: group NC-A
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.
|
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.
Other Names:
|
Other: group HRT-B
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.
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Live-birth rate
Time Frame: Live-birth after FET
|
Live-birth after FET
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
pregnancy rate
Time Frame: 2 weeks after Embryo transplantation
|
2 weeks after Embryo transplantation, people go urine HCG and blood HCG test,positive as pregnancy
|
2 weeks after Embryo transplantation
|
clinical pregnancy rate
Time Frame: 5 weeks after Embryo transplantation
|
5 weeks after Embryo transplantation,people go Vaginal B ultrasonic,being saw the gestation sac as clinical pregnancy
|
5 weeks after Embryo transplantation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2010
Primary Completion (Anticipated)
January 1, 2015
Study Completion (Anticipated)
January 1, 2015
Study Registration Dates
First Submitted
January 24, 2013
First Submitted That Met QC Criteria
January 30, 2013
First Posted (Estimate)
January 31, 2013
Study Record Updates
Last Update Posted (Estimate)
April 2, 2013
Last Update Submitted That Met QC Criteria
March 31, 2013
Last Verified
March 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Infertility
- Physiological Effects of Drugs
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Estrogens
- Contraceptive Agents, Hormonal
- Contraceptive Agents
- Reproductive Control Agents
- Contraceptive Agents, Female
- Progestins
- Estradiol
- Hormones
- Progesterone
- Estradiol 17 beta-cypionate
- Estradiol 3-benzoate
- Polyestradiol phosphate
Other Study ID Numbers
- RCT-design-FET
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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