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

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: Infertility
• Intervention / Treatment: Other: natural cycles; Drug: estradiol and progesterone

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

• Study Contact: Name: Zhang qixue, professor; Phone Number: 13602737433; Email: zhangqingxue666@yahoo.cn

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510000
      • Recruiting
      • Sun Yat-sen Memorial Hospital
      • Contact: Zhang qingxue, doctor; Phone Number: 13602797433; Email: zhangqingxue666@yahoo.cn

Participation Criteria

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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

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.	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 Names: spontaneous ovulation cycles
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.	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: Progynova; Estradiol Valerate; corpus luteum hormone; luteal hormone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Live-birth rate	Live-birth after FET

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pregnancy rate	2 weeks after Embryo transplantation, people go urine HCG and blood HCG test，positive as pregnancy	2 weeks after Embryo transplantation
clinical pregnancy rate	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

• Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Study record dates

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: randomized controlled trial; frozen-thawed embryo transfer; natural cycles; endometrium preparation protocols; hormone replacement therapy cycles
• 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