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

NCT02655146 | Unknown Phase 4 DMC

• 1 other identifier: Ferring-IIT-01
• Study Type: interventional
• Target: 700
• Locations: 1 country
• Sites: 1

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).

Conditions

Infertility

Keywords

Frozen embryo transfer,luteal support, GnRHa

Outcome Measures

Primary Outcomes (1)

• implantation rate

  5 weeks

Secondary Outcomes (1)

• clinical pregancy rate

  9 weeks

Study Arms (2)

GnRHa protocol

EXPERIMENTAL

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; Drug: E2; Drug: Progesterone; Drug: triptorelin 3.75mg

routine luteal phase protocol

OTHER

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; Drug: Progesterone; Drug: triptorelin 3.75mg

Interventions

triptorelin 0.1 DRUG

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

Also known as: decapeptyl 0.1

GnRHa protocol

E2 DRUG

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

Also known as: Progynova

GnRHa protocol; routine luteal phase protocol

Progesterone DRUG

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

GnRHa protocol; routine luteal phase protocol

triptorelin 3.75mg DRUG

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

Also known as: Diphereline 3.75mg

GnRHa protocol; routine luteal phase protocol

Eligibility Criteria

• Age: 20 Years - 37 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Chong Qing Reproducive and Genetic Institute: lead

Study Sites (1)

Chong Qing Reproductive and Genetic Institute

Chongqing, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 21975790 BACKGROUND

MeSH Terms

Conditions

Infertility

Interventions

Estradiol; Progesterone; Triptorelin Pamoate

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pregnenediones; Pregnenes; Pregnanes; Corpus Luteum Hormones; Progesterone Congeners; Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Study Officials

• Hong Ye, bachelor

  chong qing reproductive and genetic institute

  STUDY DIRECTOR

Central Study Contacts

XIU Luo, master

CONTACT

008602363839850; luoxiu1982@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2016
• First Posted: January 13, 2016
• Study Start: December 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: March 1, 2017
• Last Updated: January 13, 2016

Record last verified: 2015-12

Locations

CN (1)