To Investigate the Cumulative Live Birth Rates Using GnRH Antagonist or Agonist Protocol for COS in ART Treatment

Last updated: November 6, 2019
Sponsor: Peking University Third Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Infertility

Sterilization

Treatment

N/A

Clinical Study ID

NCT04026282
MS700623_0020
  • Ages 18-38
  • Female

Study Summary

This is a Phase IV, prospective, randomized controlled study to investigate the cumulative live birth rates (CLBRs) of gonadotrophin-releasing hormone (GnRH) antagonist protocol (GnRH-ant group) compared with the standard GnRH agonist long protocol (GnRH-a group) for controlled ovarian stimulation in supposed normal ovarian responders.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Infertile women planning to undergo IVF/ICSI cycle using conventional GnRH agonistlong protocol or GnRH antagonist protocol

  • Age ≤ 38 years old

  • Basal AFC 8~20

  • Basal FSH≤10 IU/L

  • Basal E 2 <200pmol/L

  • Normal uterus and at least one side of the normal ovary

  • Informed consent form signed

  • Willing to follow the study protocol, and able to complete this study

Exclusion

Exclusion Criteria:

  • Previous IVF/ICSI cycles >2

  • Severe hydro-salpinx (Ultrasound shows hydro salpinx﹥2cm)

  • Severe endometriosis (Grade III - IV)

  • Polycystic ovarian syndrome (PCOS)

  • History of recurrent miscarriages (>2 times of miscarriages)

  • Plan to undergo ovarian stimulation for preimplantation genetic diagnosis orpreimplantation genetic screening, oocyte donation, and social or medical freezing ofoocytes

  • Any major systemic disease that as per Investigator's discretion precludes subject forparticipation in the study

  • With pregnancy contraindications

  • Alcoholism, drug abuse, drug addiction or patients with uncured sexually transmitteddisease

  • According to the judgment of the Investigator, any medical condition or anyconcomitant surgery/medications that would interfere with evaluation of studymedications

  • Simultaneous participation in another clinical study

  • Plan to use urinary gonadotrophin during COS treatment

Study Design

Total Participants: 888
Study Start date:
December 27, 2018
Estimated Completion Date:
July 31, 2022

Study Description

This is a Phase IV, prospective, randomized controlled study to investigate the cumulative live birth rates (CLBRs) of gonadotrophin-releasing hormone (GnRH) antagonist protocol (GnRH-ant group) compared with the standard GnRH agonist long protocol (GnRH-a group) for controlled ovarian stimulation in supposed normal ovarian responders.

In this study, patients who are planning to undergo IVF/ICSI cycle aged ≤38 years old with normal ovarian reserve will be considered for enrollment. Approximately 888 patients will be enrolled at approximately 5 centers in China over a period of 10 months.

About 12-20 visits will be performed in this study for each patient. The CLBR with first live birth resulting from one initiated COS cycle will be compared between GnRH-a group and GnRH-ant group.

Connect with a study center

  • Peking University Third Hospital

    Beijing, Beijing 100000
    China

    Active - Recruiting

  • The second hospital of Hebei Medical University

    Baoding, Hebei 300000
    China

    Active - Recruiting

  • The third hospital of Zhengzhoui Medical University

    Zhengzhou, Henan 450000
    China

    Active - Recruiting

  • Jiangsu Provincial Hospital

    Nanjing, Zhejiang 210000
    China

    Active - Recruiting

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