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

NCT ID: NCT01780558

Last Updated: 2013-04-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 600 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2015-01-31

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.

Conditions

Infertility

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: OTHER

natural cycles

Intervention Type: OTHER

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.

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.

Group Type: OTHER

estradiol and progesterone

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: OTHER

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.

Intervention Type: DRUG

Other Intervention Names

spontaneous ovulation cycles; Estradiol Valerate; Progynova; corpus luteum hormone; luteal hormone

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

OTHER

Sponsor Role: lead

Responsible Party

Qingxue Zhang

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zhang qingxue, doctor

Role: STUDY_DIRECTOR

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Locations

Sun Yat-Sen Memorial Hospital

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Zhang qixue, professor

Role: CONTACT

zhangqingxue666@yahoo.cn

13602737433

Facility Contacts

Zhang qingxue, doctor

Role: primary

zhangqingxue666@yahoo.cn

13602797433

Other Identifiers

RCT-design-FET

Identifier Type: -

Identifier Source: org_study_id