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Trial · Interventional

Status unknownNot applicableRegistry data

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

Short name GnRH

NCTNCT02635607 (opens ClinicalTrials.gov in a new tab)Other idMerck-IISP-01
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Status unknown
Phase
Not applicable
Enrollment
200 participants (estimated)
Sponsor
Chong Qing Reproducive and Genetic Institute · Other
Design
Randomized · Open label (no masking)
Countries
Not stated
Start
Jan 2016
Primary completion
Dec 2016 (estimated)
Completion
Mar 2017 (estimated)
First posted
21 Dec 2015 (estimated)
Last update posted
21 Dec 2015 (estimated)
Conditions
Infertility

Timeline

1 trial

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201620172018
  1. N/A

    GnRH

    NCT02635607

    Jan 2016 to est. Mar 2017

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • Follitropin BetaDrug
  • GanirelixDrug
  • GanirelixDrug
  • rhCGDrug
  • triptorelinDrug

Arms2

  • Other

    Fixed Protocol

    Patients will start Follitropin beta stimulation on menstrual cycle day 3 and the daily dose will be fixed for the first 5 days of stimulation, a modification of the rFSH dose will be allowed from stimulation day 6 onward. Ganirelix will start fixedly on stimulation Day 5. rhCG will be administered to induce final oocyte maturation as soon as at least three follicles of ≥17 mm were observed, and triptorelin trigger will be used as a replacement in case of OHSS high risk

  • Other

    Flexible protocol

    Patients will start Follitropin beta stimulation on menstrual cycle day 3 and the daily dose will be fixed for the first 5 days of stimulation, a modification of the rFSH dose will be allowed from stimulation day 6 onward. Ganirelix will start flexibly by the promissory criterion in the flexible group. rhCG will be administered to induce final oocyte maturation as soon as at least three follicles of ≥17 mm were observed, and triptorelin trigger will be used as a replacement in case of OHSS high risk

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. the number of oocytes retrieved

    Time frame · 3 weeks

Secondary outcomes(6)

  1. Total dosage of Gn and GnRH antagonist

    Time frame · 3 weeks

  2. The incidence of premature LH surge during the stimulation

    Time frame · 3 weeks

  3. The incidence of OHSS during the study

    Time frame · 5 weeks

  4. The implantation rate

    Time frame · 5 weeks

    Registry description

    the implantation rate is defined as the number of gestational sac observed by ultrasound examination at 4 weeks after ET per 100 embryos transferred

  5. clinical pregnancy rate

    Time frame · 6 weeks

    Registry description

    Clinical pregnancy was defined as the presence of a gestation sac with a positive heartbeat detectable by transvaginal ultrasonography at 6 weeks after ET.

  6. ongoing pregnancy rate

    Time frame · 14 weeks

    Registry description

    Ongoing pregnancy was defined as a pregnancy with cardiac activity proceeding beyond 12 weeks of gestation.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2021

5 results

Fixed versus flexible antagonist protocol in women with predicted high ovarian response except PCOS: a randomized controlled trial.

Luo et al. 2021BMC pregnancy and childbirthcited by 13

PMID 33934703PMC8091520DOI 10.1186/s12884-021-03833-2PUB-33934703

CC BY5 results
Download PDFSee results (5)

Eligibility

Who could join, as posted.

Sex
Female
Age
from 20 Years up to 35 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: 1. Have an indication for COS and IVF/ICSI; 2. be \<35 years old; 3. have a BMI of 18-25kg/m2; 4. have a regular menstruation with a range of 24-35 days; 5. fulfill one of these three criteria as follow: * the number of oocytes retrieved\>15 in previous COS cycle; * Serum AMH (examined on the menstrual cycle day 2)\>3.52ng/ml; * antral follicle count (AFC) (examined by ultrasonic on the menstrual cycle day 2)\>16 6. have willingness to give informed consent Exclusion Criteria: 1. Presence of unilateral ovary absence; 2. Any difficulty on oocyte pick-up with abnormal condition of ovary and pelvic cavity; 3. Women have any clinically relevant pathology could impair embryo implantation or pregnancy continuation (uterine malformation, intermural uterine fibroids\>3cm, intrauterine adhesion,etc); 4. Women with polycystic ovary syndrome (PCOS) diagnosed by Rotterdam consensus criterion(Rotterdam, 2004) 5. Other known abnormal ovulation disorders (including but not limited to adrenal gland disease, thyroid disease and hyperprolactinemia); 6. A history of recurrent miscarriage or previous IVF cycles failure\>2; 7. A history of ovarian hypo-response in previous ovarian stimulation; 8. Women with other clinical/socio-economic factors precluding the completion of the study at the discretion of the investigator.

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