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

January 12, 2016 updated by: Chong Qing Reproducive and Genetic Institute

Implantation in Frozen Embryo Transfer

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

700

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • ChongQing, China
        • Recruiting
        • Chong Qing Reproductive and Genetic Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 37 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
implantation rate
Time Frame: 5 weeks
5 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
clinical pregancy rate
Time Frame: 9 weeks
9 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chong Qing Reproducive and Genetic Institute

Investigators

  • Study Director: Hong Ye, bachelor, Chong Qing Reproductive and Genetic Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2015

Primary Completion (ANTICIPATED)

December 1, 2016

Study Completion (ANTICIPATED)

March 1, 2017

Study Registration Dates

First Submitted

January 12, 2016

First Submitted That Met QC Criteria

January 12, 2016

First Posted (ESTIMATE)

January 13, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

January 13, 2016

Last Update Submitted That Met QC Criteria

January 12, 2016

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Ferring-IIT-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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