NCT01780558

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

January 24, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 31, 2013

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

April 2, 2013

Status Verified

March 1, 2013

Enrollment Period

5 years

First QC Date

January 24, 2013

Last Update Submit

March 31, 2013

Conditions

Infertility

Keywords

endometrium preparation protocolsfrozen-thawed embryo transfernatural cycleshormone replacement therapy cyclesrandomized controlled trial

Outcome Measures

Primary Outcomes (1)

  • Live-birth rate

    Live-birth after FET

Secondary Outcomes (2)

  • pregnancy rate

    2 weeks after Embryo transplantation

  • clinical pregnancy rate

    5 weeks after Embryo transplantation

Study Arms (2)

group NC-A

OTHER

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

group HRT-B

OTHER

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

Interventions

natural cyclesOTHER

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.

Also known as: spontaneous ovulation cycles
group NC-A
estradiol and progesteroneDRUG

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.

Also known as: Estradiol Valerate, Progynova, corpus luteum hormone, luteal hormone
group HRT-B

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sun Yat-Sen Memorial Hospital

Guangzhou, Guangdong, 510000, China

RECRUITING

MeSH Terms

Conditions

Infertility

Interventions

EstradiolProgesterone

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Intervention Hierarchy (Ancestors)

EstrenesEstranesSteroidsFused-Ring CompoundsPolycyclic CompoundsEstradiol CongenersGonadal Steroid HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPregnenedionesPregnenesPregnanesCorpus Luteum HormonesProgesterone Congeners

Study Officials

  • Zhang qingxue, doctor

    Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

    STUDY DIRECTOR

Central Study Contacts

Zhang qixue, professor

CONTACT

13602737433zhangqingxue666@yahoo.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

January 24, 2013

First Posted

January 31, 2013

Study Start

January 1, 2010

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

April 2, 2013

Record last verified: 2013-03

Locations

CN(1)