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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sponsor:
Information provided by (Responsible Party):
Qingxue Zhang, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
ClinicalTrials.gov Identifier:
NCT01780558
First received: January 24, 2013
Last updated: March 31, 2013
Last verified: March 2013
  Purpose

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.


Condition Intervention
Infertility
Other: natural cycles
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: A Randomized Controlled Study:the Different Outcomes Between Natural Cycle and Hormon Replacement Cycle in FET

Resource links provided by NLM:


Further study details as provided by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University:

Primary Outcome Measures:
  • Live-birth rate [ Time Frame: Live-birth after FET ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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: 600
Study Start Date: January 2010
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: spontaneous ovulation cycles
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:
  • Estradiol Valerate
  • Progynova
  • corpus luteum hormone
  • luteal hormone

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.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01780558

Contacts
Contact: Zhang qixue, professor 13602737433 zhangqingxue666@yahoo.cn

Locations
China, Guangdong
Sun Yat-Sen Memorial Hospital Recruiting
Guangzhou, Guangdong, China, 510000
Contact: Zhang qingxue, doctor    13602797433    zhangqingxue666@yahoo.cn   
Sponsors and Collaborators
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Investigators
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: NCT01780558     History of Changes
Other Study ID Numbers: RCT-design-FET
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:
endometrium preparation protocols
frozen-thawed embryo transfer
natural cycles
hormone replacement therapy cycles
randomized controlled trial

Additional relevant MeSH terms:
Estrogens
Infertility
Genital Diseases, Male
Genital Diseases, Female
Progesterone
Estradiol
Polyestradiol phosphate
Hormones
Estradiol valerate
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Progestins
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Contraceptive Agents
Reproductive Control Agents
Therapeutic Uses
Contraceptive Agents, Female

ClinicalTrials.gov processed this record on July 24, 2014