A Study:the Different Outcomes Between Natural Cycle and Hormone Replacement Cycle in FET
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Infertility |
Other: natural cycles Drug: estradiol and progesterone |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| Official Title: | A Randomized Controlled Study:the Different Outcomes Between Natural Cycle and Hormon Replacement Cycle in FET |
- Live-birth rate [ Time Frame: Live-birth after FET ] [ Designated as safety issue: No ]
- pregnancy rate [ Time Frame: 2 weeks after Embryo transplantation ] [ Designated as safety issue: No ]2 weeks after Embryo transplantation, people go urine HCG and blood HCG test，positive as pregnancy
- clinical pregnancy rate [ Time Frame: 5 weeks after Embryo transplantation ] [ Designated as safety issue: No ]5 weeks after Embryo transplantation,people go Vaginal B ultrasonic，being saw the gestation sac as clinical pregnancy
| Estimated Enrollment: | 600 |
| Study Start Date: | January 2010 |
| Estimated Study Completion Date: | January 2015 |
| Estimated Primary Completion Date: | January 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
Other: 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 Name: spontaneous ovulation cycles
|
|
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.
|
Drug: estradiol and progesterone
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:
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 40 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations| Contact: Zhang qixue, professor | 13602737433 | zhangqingxue666@yahoo.cn |
| China, Guangdong | |
| Sun Yat-Sen Memorial Hospital | Recruiting |
| Guangzhou, Guangdong, China, 510000 | |
| Contact: Zhang qingxue, doctor 13602797433 zhangqingxue666@yahoo.cn | |
| Study Director: | Zhang qingxue, doctor | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University |
More Information
No publications provided
| Responsible Party: | Qingxue Zhang, professor, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University |
| ClinicalTrials.gov Identifier: | NCT01780558 History of Changes |
| Other Study ID Numbers: | RCT-design-FET |
| Study First Received: | January 24, 2013 |
| Last Updated: | March 31, 2013 |
| Health Authority: | China: Ministry of Health |
Keywords provided by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University:
|
endometrium preparation protocols frozen-thawed embryo transfer natural cycles hormone replacement therapy cycles randomized controlled trial |
Additional relevant MeSH terms:
|
Infertility Genital Diseases, Male Genital Diseases, Female Progesterone Estradiol Polyestradiol phosphate Hormones Estradiol valerate Estradiol 3-benzoate Estradiol 17 beta-cypionate |
Progestins Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions Estrogens Contraceptive Agents Reproductive Control Agents Therapeutic Uses Contraceptive Agents, Female |
ClinicalTrials.gov processed this record on June 18, 2013