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

Sun Yat-sen University

Status: Unknown

Conditions: Infertility

Treatments: Drug: estradiol and progesterone; Other: natural cycles

Study type: Interventional

Funder types: Other

Identifiers

NCT01780558

RCT-design-FET

Details and patient eligibility

About

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.

Full 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.

Enrollment: 600 estimated patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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600 participants in 2 patient groups

group NC-A

Other group

Description:

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.

Treatment:

Other: natural cycles

group HRT-B

Other group

Description:

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.

Treatment:

Drug: estradiol and progesterone