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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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ClinicalTrials.gov Identifier: NCT02655146
Recruitment Status : Unknown
Verified December 2015 by Chong Qing Reproducive and Genetic Institute.
Recruitment status was:  Recruiting
First Posted : January 13, 2016
Last Update Posted : January 13, 2016
Sponsor:
Information provided by (Responsible Party):
Chong Qing Reproducive and Genetic Institute

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
Infertility Drug: triptorelin 0.1 Drug: E2 Drug: Progesterone Drug: triptorelin 3.75mg 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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : December 2015
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : March 2017

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 Name: decapeptyl 0.1

Drug: E2
Patients will be on the Progynova tablets 4-10mg daily at least 14 days.
Other Name: 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 Name: Diphereline 3.75mg

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 Name: 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 Name: Diphereline 3.75mg




Primary Outcome Measures :
  1. implantation rate [ Time Frame: 5 weeks ]

Secondary Outcome Measures :
  1. clinical pregancy rate [ Time Frame: 9 weeks ]


Information from the National Library of Medicine

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02655146


Contacts
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Contact: XIU Luo, master 008602363839850 luoxiu1982@163.com

Locations
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China
Chong Qing Reproductive and Genetic Institute Recruiting
ChongQing, China
Contact: Xiu Luo, master    008602363839850    luoxiu1982@163.com   
Sponsors and Collaborators
Chong Qing Reproducive and Genetic Institute
Investigators
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Study Director: Hong Ye, bachelor chong qing reproductive and genetic institute

Publications:
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Responsible Party: Chong Qing Reproducive and Genetic Institute
ClinicalTrials.gov Identifier: NCT02655146    
Other Study ID Numbers: Ferring-IIT-01
First Posted: January 13, 2016    Key Record Dates
Last Update Posted: January 13, 2016
Last Verified: December 2015
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Chong Qing Reproducive and Genetic Institute:
Frozen embryo transfer,luteal support, GnRHa
Additional relevant MeSH terms:
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Infertility
Genital Diseases, Male
Genital Diseases, Female
Triptorelin Pamoate
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Progesterone
Estradiol
Polyestradiol phosphate
Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Luteolytic Agents
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Estrogens