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

Sponsor
Chong Qing Reproducive and Genetic Institute (Other)
Overall Status
Unknown status
CT.gov ID
NCT02655146
Collaborator
(none)
700
1
2
15
46.7

Study Details

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).

Condition or Disease Intervention/Treatment Phase
Phase 4

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
700 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Implantation in Frozen Embryo Transfer
Study Start Date :
Dec 1, 2015
Anticipated Primary Completion Date :
Dec 1, 2016
Anticipated Study Completion Date :
Mar 1, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: GnRHa protocol

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.

Drug: triptorelin 0.1
a single dose of decapeptyl 0.1 s.c. on the 3rd day of embryo transfer with routine luteal phase support.
Other Names:
  • decapeptyl 0.1
  • Drug: E2
    Patients will be on the Progynova tablets 4-10mg daily at least 14 days.
    Other Names:
  • Progynova
  • Drug: Progesterone
    After ultrasound and hormorne tests, progesterone 100mg intramuscular injection is allocated with Progynova.

    Drug: triptorelin 3.75mg
    as a pretreatment of E2 in some subjects with a fail history of hormonal artificially endometrium preparing.
    Other Names:
  • Diphereline 3.75mg
  • Other: routine luteal phase protocol

    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 .

    Drug: E2
    Patients will be on the Progynova tablets 4-10mg daily at least 14 days.
    Other Names:
  • Progynova
  • Drug: Progesterone
    After ultrasound and hormorne tests, progesterone 100mg intramuscular injection is allocated with Progynova.

    Drug: triptorelin 3.75mg
    as a pretreatment of E2 in some subjects with a fail history of hormonal artificially endometrium preparing.
    Other Names:
  • Diphereline 3.75mg
  • Outcome Measures

    Primary Outcome Measures

    1. implantation rate [5 weeks]

    Secondary Outcome Measures

    1. clinical pregancy rate [9 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 37 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Chong Qing Reproductive and Genetic Institute ChongQing China

    Sponsors and Collaborators

    • Chong Qing Reproducive and Genetic Institute

    Investigators

    • Study Director: Hong Ye, bachelor, chong qing reproductive and genetic institute

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Chong Qing Reproducive and Genetic Institute
    ClinicalTrials.gov Identifier:
    NCT02655146
    Other Study ID Numbers:
    • Ferring-IIT-01
    First Posted:
    Jan 13, 2016
    Last Update Posted:
    Jan 13, 2016
    Last Verified:
    Dec 1, 2015
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Keywords provided by Chong Qing Reproducive and Genetic Institute
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 13, 2016