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Effectiveness and Safety Study of Fixed Versus Flexible of Gonadotropin-releasing Hormone Antagonist Protocol

NCT02635607 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2015-12-21

No results posted yet for this study

Summary

The purpose of study is to compare the effectiveness of the Day-5 fixed administration of GnRH antagonist versus flexible administration of GnRH antagonist during ovarian stimulation in Chinese women with predicted high ovarian response, and the hypotheses is that the number of oocyte retrieved in fixed protocol is not inferior to GnRH antagonist flexible protocol.

Conditions

Interventions

DRUG

Follitropin Beta

Patients will start stimulation with a daily s.c. injection of 150IU follitropin beta on menstrual cycle day 3. A modification of the rFSH dose will be allowed from stimulation day 6 onward in case that a high ovarian response occurs at the discretion of the investigator.

DRUG

Ganirelix

Ganirelix 0.25mg daily s.c. will start after 4 days of rFSH stimulation

DRUG

Ganirelix

Ganirelix 0.25mg daily s.c. will start when at least one of the following criteria are fulfilled: (i) the presence of at least one follicle measuring≥12 mm; (ii) serum E2 levels\>600 pg/ml; and (iii) serum LH levels\>10 IU/l.

DRUG

rhCG

An amount of 250ug rhCG will be administered to induce final oocyte maturation as soon as at least three follicles of ≥17 mm were observed

DRUG

triptorelin

0.2mg triptorelin will replace rHCG to trigger in case of high risk of overstimulation

Sponsors & Collaborators

Principal Investigators

  • Hong Ye, bachelor · Genetic and Reproductive Institute, Chongqing Obstetrics and Gynecology Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
35 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2016-12-31
Completion
2017-03-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02635607 on ClinicalTrials.gov