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the Effects of GnRHa Add up to Routine Luteal Phase Support on Frozen Embryo Implantation in Frozen Embryo Transfer .

Primary Purpose

Infertility

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
triptorelin 0.1
E2
Progesterone
triptorelin 3.75mg
Sponsored by
Chong Qing Reproducive and Genetic Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility focused on measuring Frozen embryo transfer,luteal support, GnRHa

Eligibility Criteria

20 Years - 37 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • infertile women with frozen thawed embryo transfer after HRT endometrial preparation.
  • more than 20 years old, and less than 37 years old.
  • BMI less than 28kg/m2.
  • more than 1 transplantable embryo after thawing.
  • patients should sign the informed consent and have the willing to follow up.

Exclusion Criteria:

  • uterine malformation
  • diameter of intramural myoma more than 3cm
  • the thickness of endometrium less than 7mm on the progesterone supportive day.

Sites / Locations

  • Chong Qing Reproductive and Genetic InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

GnRHa protocol

routine luteal phase protocol

Arm Description

All subjects are artificially preparing endometrium starting on day 3-5 of the cycle with oral E2 (Progynova) 4-10mg/day at least 14 days. After ultrasound and hormone tests, progesterone 100mg/day intramuscular injection is allocated with E2.In the meanwhile, if the subjects have a fail history of hormonal artificially preparing endometrium, such as an early ovulation, a singal dose of triptorelin 3.75mg would be intramuscular injected before E2 was used as a pretreatment. Then a maximum of two embryos are transferred when endometrium is perfectly prepared. All subjects receive routine luteal phase support with E2 and progesterone .A single dose of Triptorelin 0.1mg is administrated on the 3rd day after embryo implanted with routine luteal phase support.

All subjects are artificially preparing endometrium starting on day 3-5 of the cycle with oral E2 4-10mg/day at least 14 days. After ultrasound and hormone tests, progesterone 100mg/day intramuscular injection is allocated with E2. In the meanwhile, if the subjects have a fail history of hormonal artificially preparing endometrium, such as an early ovulation, a singal dose of triptorelin 3.75mg would be intramuscular injected before E2 was used as a pretreatment. Then a maximum of two embryos are transferred when endometrium is perfectly prepared. All subjects receive routine luteal phase support with E2 and progesterone .

Outcomes

Primary Outcome Measures

implantation rate

Secondary Outcome Measures

clinical pregancy rate

Full Information

First Posted
January 12, 2016
Last Updated
January 12, 2016
Sponsor
Chong Qing Reproducive and Genetic Institute
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1. Study Identification

Unique Protocol Identification Number
NCT02655146
Brief Title
the Effects of GnRHa Add up to Routine Luteal Phase Support on Frozen Embryo Implantation in Frozen Embryo Transfer .
Official Title
Implantation in Frozen Embryo Transfer
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Unknown status
Study Start Date
December 2015 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
March 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chong Qing Reproducive and Genetic Institute

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The aim of the present prospective randomized controlled study was to determine the effects of GnRHa add up to routine luteal phase support on frozen embryo implantation in frozen embryo transfer (FET).
Detailed Description
Some recent data have suggested a beneficial effect of GnRHa administered in the luteal phase on the outcome of assisted reproduction techniques. In those studies, the dose and administration time of GnRHa are inconsistent. Single administration on third day after embryo transfer and multiple dose injection during luteal phase are the most common way. The GnRHa included Triptorelin 0.1mg, Leuprorelin 1mg and Buserelin 600ug et al. The exact underlying mechanism is still not clear, although it has been hypothesized that GnRH agonist either supports the corpus luteum function by inducing LH secretion by the pituitary gonadotrophin cells or stimulates the endometrium GnRH receptors . Tesarik et al.postulated a direct effect of GnRH agonist on the embryo, evidenced by increased β-HCG secretion. Currently, available data suggest that inadvertent administration of a GnRH agonist during a conception cycle is not accompanied by an increased risk of birth defects. On the basis of the currently strong available evidence, it appears that GnRH agonist supplementation during luteal phase significantly improve the outcome of ART treatment. Most of the former researches focused only on fresh embryo transfer in IVF/ICSI cycles. In one prospective controlled study, a single dose of Triptorelin 0.1mg was administrated 6 days after ICSI in oocyte donor cycles and the implantation rate was improved significantly.GnRH agonist administration at the time of implantation enhances embryo developmental potential, probably by a direct effect on the embryo.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
Frozen embryo transfer,luteal support, GnRHa

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
700 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
GnRHa protocol
Arm Type
Experimental
Arm Description
All subjects are artificially preparing endometrium starting on day 3-5 of the cycle with oral E2 (Progynova) 4-10mg/day at least 14 days. After ultrasound and hormone tests, progesterone 100mg/day intramuscular injection is allocated with E2.In the meanwhile, if the subjects have a fail history of hormonal artificially preparing endometrium, such as an early ovulation, a singal dose of triptorelin 3.75mg would be intramuscular injected before E2 was used as a pretreatment. Then a maximum of two embryos are transferred when endometrium is perfectly prepared. All subjects receive routine luteal phase support with E2 and progesterone .A single dose of Triptorelin 0.1mg is administrated on the 3rd day after embryo implanted with routine luteal phase support.
Arm Title
routine luteal phase protocol
Arm Type
Other
Arm Description
All subjects are artificially preparing endometrium starting on day 3-5 of the cycle with oral E2 4-10mg/day at least 14 days. After ultrasound and hormone tests, progesterone 100mg/day intramuscular injection is allocated with E2. In the meanwhile, if the subjects have a fail history of hormonal artificially preparing endometrium, such as an early ovulation, a singal dose of triptorelin 3.75mg would be intramuscular injected before E2 was used as a pretreatment. Then a maximum of two embryos are transferred when endometrium is perfectly prepared. All subjects receive routine luteal phase support with E2 and progesterone .
Intervention Type
Drug
Intervention Name(s)
triptorelin 0.1
Other Intervention Name(s)
decapeptyl 0.1
Intervention Description
a single dose of decapeptyl 0.1 s.c. on the 3rd day of embryo transfer with routine luteal phase support.
Intervention Type
Drug
Intervention Name(s)
E2
Other Intervention Name(s)
Progynova
Intervention Description
Patients will be on the Progynova tablets 4-10mg daily at least 14 days.
Intervention Type
Drug
Intervention Name(s)
Progesterone
Intervention Description
After ultrasound and hormorne tests, progesterone 100mg intramuscular injection is allocated with Progynova.
Intervention Type
Drug
Intervention Name(s)
triptorelin 3.75mg
Other Intervention Name(s)
Diphereline 3.75mg
Intervention Description
as a pretreatment of E2 in some subjects with a fail history of hormonal artificially endometrium preparing.
Primary Outcome Measure Information:
Title
implantation rate
Time Frame
5 weeks
Secondary Outcome Measure Information:
Title
clinical pregancy rate
Time Frame
9 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
37 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: infertile women with frozen thawed embryo transfer after HRT endometrial preparation. more than 20 years old, and less than 37 years old. BMI less than 28kg/m2. more than 1 transplantable embryo after thawing. patients should sign the informed consent and have the willing to follow up. Exclusion Criteria: uterine malformation diameter of intramural myoma more than 3cm the thickness of endometrium less than 7mm on the progesterone supportive day.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
XIU Luo, master
Phone
008602363839850
Email
luoxiu1982@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hong Ye, bachelor
Organizational Affiliation
chong qing reproductive and genetic institute
Official's Role
Study Director
Facility Information:
Facility Name
Chong Qing Reproductive and Genetic Institute
City
ChongQing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiu Luo, master
Phone
008602363839850
Email
luoxiu1982@163.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
21975790
Citation
van der Linden M, Buckingham K, Farquhar C, Kremer JA, Metwally M. Luteal phase support for assisted reproduction cycles. Cochrane Database Syst Rev. 2011 Oct 5;(10):CD009154. doi: 10.1002/14651858.CD009154.pub2.
Results Reference
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the Effects of GnRHa Add up to Routine Luteal Phase Support on Frozen Embryo Implantation in Frozen Embryo Transfer .

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