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

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:
NCT01780610
First received: January 24, 2013
Last updated: March 31, 2013
Last verified: March 2013
  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
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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • 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


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: 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
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
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

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
Criteria

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
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: NCT01780610

Contacts
Contact: Zhang qixue, professor 13602737433

Locations
China, Guangdong
Sun Yat-Sen Memorial Hospital Recruiting
Guangzhou, Guangdong, China, 510000
Contact: Zhang qingxue, doctor    13602797433      
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: 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:
endometrium preparation protocols
frozen-thawed embryo transfer
irregular cycle
randomized controlled trial

Additional relevant MeSH terms:
Estrogens
Infertility
Genital Diseases, Male
Genital Diseases, Female
Chorionic Gonadotropin
Estradiol valerate
Estradiol 17 beta-cypionate
Estradiol 3-benzoate
Progesterone
Estradiol
Polyestradiol phosphate
Hormones
Letrozole
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Progestins
Hormones, Hormone Substitutes, and Hormone Antagonists
Contraceptive Agents
Contraceptive Agents, Female
Antineoplastic Agents
Aromatase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 27, 2014