The Effects of Two Endometrium Preparation Protocols in Frozen-thawed Embryo Transfer in Women With Irregular Cycles

Sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University (Other)

Overall Status

Unknown status

CT.gov ID

NCT01780610

Collaborator

(none)

670

Enrollment

Location

Arms

Duration (Months)

18.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

There are two main cycle regimens used for endometrial preparation for frozen embryo transfer （FET) in women with irregular cycles: 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 frozen embryo transfer cycle regimen to plan more advantage. The purpose of this study was to compare the pregnancy outcome of hormone replacement therapy cycles (HRT) and ovulation induced cycles (OI) in women with irregular cycles.

Condition or Disease	Intervention/Treatment	Phase
Infertility	Drug: Letrozole and human chorionic gonadotrophin Drug: estradiol and progesterone	N/A

Detailed Description

This study is a prospective randomized controlled trial. Patients with irregular 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 OI-FET cycle (group OI-A) or the HRT-FET cycle (group HRT-B). In group OI-A, the follicular development is supported by Letrozole(LE) 2.5mg,once daily,is introduced on cycle day 3 .And on cycle day 10 , a Vagina ultrasound is introduced to monitor the development of the follicular ,following by intramuscular gonadotrophin 37.5~75 IU/d until there is a Luteinizing Hormone(LH) surge or ovulation .On the day appearing Luteinizing Hormone surge，patient is always introduced intramuscular human chorionic gonadotrophin(HCG) 10000 IU.If there is sill no Luteinizing Hormone surge when the follicle is 20-24mm ,the ovulation will be induced by HCG.Then the luteum is supported by HCG 2000-2500 IU/3d.Transfer of thawed embryos will be performed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

670 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

The Effects of Two Endometrium Preparation Protocols in Frozen-thawed Embryo Transfer in Women With Irregular Cycles

Study Start Date :

Jan 1, 2012

Anticipated Primary Completion Date :

Jan 1, 2015

Anticipated Study Completion Date :

Jan 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Other: group OI-A Patients with irregular 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 Letrozole and human chorionic gonadotrophin ovulation induced cycles.	Drug: Letrozole and human chorionic gonadotrophin the follicular development is supported by Letrozole(LE) 2.5mg,once daily is introduced on cycle day 3 .And on cycle day 10 , a Vagina ultrasound is introduced to monitor the development of the follicular ,following by intramuscular gonadotrophin 37.5~75 IU/d until there is a Luteinizing Hormone(LH) surge or ovulation .On the day appearing Luteinizing Hormone surge，patients is always introduced intramuscular human chorionic gonadotrophin(HCG) 10000 IU.If there is sill no Luteinizing Hormone surge when the follicle is 20-24mm ,the ovulation will be induced by HCG.Then the luteum was supported by HCG 2000-2500 IU/3d.Transfer of thawed embryos will be performed 3 days after ovulation is observed. Other Names: Letrozole tablets HCG Chorionic gonadotrophin Chorionic gonadotropic hormone
Other: group HRT-B Patients with irregular 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 will be randomized to receive the estradiol and progesterone replacement therapy cycles.	Drug: estradiol and progesterone oral estradiol, 2 mg, once daily, was introduced on cycle day 3 with an increasing doses protocol. If the endometrial thickness was greater than 7mm, progesterone 40-60 mg in oil was administered via intramuscular injection. Transfer of thawed embryos was performed 3 days later Other Names: Estradiol Valerate Progynova 3,20-pregnene-4; 4-pregnene-3,20-dione corpus luteum hormone luteal hormone

Arm

Intervention/Treatment

Other: group OI-A

Patients with irregular 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 Letrozole and human chorionic gonadotrophin ovulation induced cycles.

Drug: Letrozole and human chorionic gonadotrophin

the follicular development is supported by Letrozole(LE) 2.5mg,once daily is introduced on cycle day 3 .And on cycle day 10 , a Vagina ultrasound is introduced to monitor the development of the follicular ,following by intramuscular gonadotrophin 37.5~75 IU/d until there is a Luteinizing Hormone(LH) surge or ovulation .On the day appearing Luteinizing Hormone surge，patients is always introduced intramuscular human chorionic gonadotrophin(HCG) 10000 IU.If there is sill no Luteinizing Hormone surge when the follicle is 20-24mm ,the ovulation will be induced by HCG.Then the luteum was supported by HCG 2000-2500 IU/3d.Transfer of thawed embryos will be performed 3 days after ovulation is observed.

Other Names:

Letrozole tablets

HCG

Chorionic gonadotrophin

Chorionic gonadotropic hormone

Other: group HRT-B

Patients with irregular 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 will be randomized to receive the estradiol and progesterone replacement therapy cycles.

Drug: estradiol and progesterone

oral estradiol, 2 mg, once daily, was introduced on cycle day 3 with an increasing doses protocol. If the endometrial thickness was greater than 7mm, progesterone 40-60 mg in oil was administered via intramuscular injection. Transfer of thawed embryos was performed 3 days later

Other Names:

Estradiol Valerate

Progynova

3,20-pregnene-4; 4-pregnene-3,20-dione

corpus luteum hormone

luteal hormone

Outcome Measures

Primary Outcome Measures

ongoing pregnancy rate [12 weeks after pregnancy]
12 weeks after pregnancy,people go Vaginal B ultrasonic examination，being saw gestational sac and heart tube beat as ongoing pregnancy

Secondary Outcome Measures

pregnancy rate [2 weeks after Embryo transplantation]
2 weeks after Embryo transplantation, people go urine HCG and blood HCG test，positive as pregnancy
clinical pregnancy rate [5 weeks after Embryo transplantation]
5 weeks after Embryo transplantation,people go Vaginal B ultrasonic，being saw the gestation sac as clinical pregnancy

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Age forty years old or less
Has irregular Menstruation (cycle more than 35 days or less than 24 days ) or has regulation Menstruation but previous data suggest that abnormal 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 ovulation induction（OI)+FET before or the growth of endometrium not good in the HRT+FET before