The Effects of Two Endometrium Preparation Protocols in Frozen-thawed Embryo Transfer in Women With Irregular Cycles
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Purpose
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 | Intervention |
|---|---|
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Infertility |
Drug: Letrozole and human chorionic gonadotrophin 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: | The Effects of Two Endometrium Preparation Protocols in Frozen-thawed Embryo Transfer in Women With Irregular Cycles |
- ongoing pregnancy rate [ Time Frame: 12 weeks after pregnancy ] [ Designated as safety issue: No ]12 weeks after pregnancy,people go Vaginal B ultrasonic examination，being saw gestational sac and heart tube beat as ongoing pregnancy
- 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: | 670 |
| Study Start Date: | January 2012 |
| Estimated Study Completion Date: | January 2015 |
| Estimated Primary Completion Date: | January 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
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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.
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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:
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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.
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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:
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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.
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 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
Contacts and Locations| Contact: Zhang qixue, professor | 13602737433 |
| China, Guangdong | |
| Sun Yat-Sen Memorial Hospital | Recruiting |
| Guangzhou, Guangdong, China, 510000 | |
| Contact: Zhang qingxue, doctor 13602797433 | |
| 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: | NCT01780610 History of Changes |
| Other Study ID Numbers: | SunYatsenU2H- QZhang |
| 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:
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endometrium preparation protocols frozen-thawed embryo transfer irregular cycle randomized controlled trial |
Additional relevant MeSH terms:
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Infertility Genital Diseases, Male Genital Diseases, Female Chorionic Gonadotropin Estradiol valerate Estradiol 3-benzoate Estradiol 17 beta-cypionate Progesterone Estradiol Polyestradiol phosphate Hormones Letrozole Reproductive Control Agents |
Physiological Effects of Drugs Pharmacologic Actions Therapeutic Uses Progestins Hormones, Hormone Substitutes, and Hormone Antagonists Estrogens Contraceptive Agents Contraceptive Agents, Female Antineoplastic Agents Aromatase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on June 18, 2013