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

NCT ID: NCT02655146

Last Updated: 2016-01-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 700 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-31
• Study Completion Date: 2017-03-31

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.

Conditions

Infertility

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

triptorelin 0.1

Intervention Type: DRUG

a single dose of decapeptyl 0.1 s.c. on the 3rd day of embryo transfer with routine luteal phase support.

E2

Intervention Type: DRUG

Patients will be on the Progynova tablets 4-10mg daily at least 14 days.

Progesterone

Intervention Type: DRUG

After ultrasound and hormorne tests, progesterone 100mg intramuscular injection is allocated with Progynova.

triptorelin 3.75mg

Intervention Type: DRUG

as a pretreatment of E2 in some subjects with a fail history of hormonal artificially endometrium preparing.

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 .

Group Type: OTHER

E2

Intervention Type: DRUG

Patients will be on the Progynova tablets 4-10mg daily at least 14 days.

Progesterone

Intervention Type: DRUG

After ultrasound and hormorne tests, progesterone 100mg intramuscular injection is allocated with Progynova.

triptorelin 3.75mg

Intervention Type: DRUG

as a pretreatment of E2 in some subjects with a fail history of hormonal artificially endometrium preparing.

Interventions

triptorelin 0.1

a single dose of decapeptyl 0.1 s.c. on the 3rd day of embryo transfer with routine luteal phase support.

Intervention Type: DRUG

E2

Patients will be on the Progynova tablets 4-10mg daily at least 14 days.

Intervention Type: DRUG

Progesterone

After ultrasound and hormorne tests, progesterone 100mg intramuscular injection is allocated with Progynova.

Intervention Type: DRUG

triptorelin 3.75mg

as a pretreatment of E2 in some subjects with a fail history of hormonal artificially endometrium preparing.

Intervention Type: DRUG

Other Intervention Names

decapeptyl 0.1; Progynova; Diphereline 3.75mg

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 37 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Chong Qing Reproducive and Genetic Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hong Ye, bachelor

Role: STUDY_DIRECTOR

chong qing reproductive and genetic institute

Locations

Chong Qing Reproductive and Genetic Institute

Chongqing, , China

Site Status: RECRUITING

Countries

China

Central Contacts

XIU Luo, master

Role: CONTACT

luoxiu1982@163.com

008602363839850

Facility Contacts

Xiu Luo, master

Role: primary

luoxiu1982@163.com

008602363839850

References

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.

Reference Type: BACKGROUND

PMID: 21975790 (View on PubMed)

Other Identifiers

Ferring-IIT-01

Identifier Type: -

Identifier Source: org_study_id